Medtech approvals: FDA releases October 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015:

Summary of PMA Originals & Supplements Approved

• Originals: 9
• Supplements: 133

Summary of PMA Originals Under Review

• Total Under Review: 58
• Total Active: 32
• Total On Hold: 26

Summary of PMA Supplements Under Review

• Total Under Review: 597
• Total Active: 433
• Total On Hold: 164

Summary of All PMA Submissions

• Originals: 7
• Supplements: 74

Summary of PMA Supplement PMA Approval/Denial Decision Times

• Number of Approvals: 133
• Number of Denials: 0
• Average Days Fr Receipt to Decision (Total Time): 161.5
• FDA Time: 97.9 Days
• MFR Time: 63.6 Days

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P150003 10/2/15	SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System. This device is indicated for improving luminal diameter in patients with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter in lesions ≤34 mm in length.
P150013 10/2/15	PD-L1 IHC 22C3 pharmDx	Dako North America, Inc. Carpinteria, CA 93013	Approval for the PD-L1 IHC 22C3 pharmDx. This device is indicated for the following: PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 Antibody intended for use in the detection of PD-L1protein in formalin fixed, paraffin embedded (FFPE) Non-Small Cell Lung Cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining. The specimen should be considered PD-L1 positive if TPS ≥50% of the viable tumor cells exhibit membrane staining at any intensity. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab).
P150014 10/14/15	cobas® HBV	Roche Molecular Systems, Inc. Pleasanton, CA 94588	Approval for the cobas HBV. This device is indicated for: cobas HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human EDTA plasma or serum of HBV-infected individuals. This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas HBV must be interpreted within the context of all relevant clinical and laboratory findings. The cobas HBV is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection.
P150015 10/14/15	cobas® HCV	Roche Molecular Systems, Inc. Pleasanton, CA 94588	Approval for the cobas HCV. This device is indicated for: cobas HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV antibody positive or HCV-infected individuals. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay. cobas HCV is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV.  Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. cobas HCV is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay can be used to measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response. The results must be interpreted within the context of all relevant clinical and laboratory findings. cobas HCV has not been approved for use as a screening test for the presence of HCV in blood or blood products. Assay performance characteristics have been established for individuals treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other DAA combination therapies are used.
P150025 10/9/15	PD-L1 IHC 28-8 pharmDx	Dako North America, Inc. Carpinteria, CA 93013	Approval for the PD-L1 IHC 28-8 Pharmdx. This device is indicated for the following: 1) PD-L1 IHC 28-8 pharmDx is a qualitative immunohisto-chemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48; 2) PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity; and 3) PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO (nivolumab).

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P820003/S132 10/19/15 180-Day	Symbios, Synergyst	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P850051/S082 10/19/15 180-Day	Activitrax, Legend, Micro Minix, Minix, Premier, Prevail, Vitatron Legacy	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P860057/S127 10/19/15 135-Day	Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral Bioprostheses	Edwards Lifesciences, LLC. Irvine, CA 92614	Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier.
P890003/S326 10/19/15 180-Day	Remote Control Software for the 2090 Programmer, Analyzer Software, Application Software, Elite II, Elite, Lead Analysis Device, Lead Analyzer, Minuet, Preva, Prodigy, Programmer Software, SessionSync Feature, Synergyst II, Thera, Vitatron Legacy, Vitatron Visa	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P890003/S336 10/7/15 Real-Time	CareLink Express Monitor, Cardiosight Reader, CareLink Home Monitor	Medtronic Inc. Mounds View, MN 55112	Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P900061/S133 10/19/15 180-Day	Medtronic GEM ICD, Medtronic Jewel ICD, Medtronic Jewel Plus ICD, Medtronic Micro Jewel ICD, Medtronic PCD Tachyarrhythmia Control System	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P910001/S078 10/20/15 Real-Time	CVX-300/CVX-300-P Excimer Laser System	Spectranetics, Inc. Colorado Springs, CO 80921	Approval for a minor design change to the Anti-Reflective coating that is applied to the laser vessel windows.
P920015/S146 10/19/15 180-Day	Medtronic PCD Tachyarrhythmia Control System	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P930022/S017 10/19/15 180-Day	Legend Plus	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P960004/S059 10/8/15 180-Day	FINELINE II Sterox and Sterox EZ Endocardial Pacing Leads	Boston Scientific Corporation St Paul, MN 55112	Approval for the following: 1) A sterilization process change from Oxyfume to 100% Ethylene Oxide; 2) Drug specification changes; 3) Labeling changes; 4) To finish remaining 3 months of Lot Release Study for passive fixation leads as non-clinical post approval study; 4) Manufacturing changes to reduce elution variation; 5) To update active fixation batch release study protocol to implement new manufacturing changes; and 6) To complete 12 month Lot Release Study as non-clinical post approval study.
P960040/S354 10/2/15 Real-Time	DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, ORIGEN EL ICD, ORIGEN MINI ICD	Boston Scientific Corporation St. Paul, MN 55112	Approval for design changes to the NG3 and NG2.5 high voltage capacitors for the devices.
P960043/S090 10/9/15 180-Day	Perclose ProGlide Suture-Mediated Closure System	Abbott Vascular Temecula, CA 92591	Approval for new manufacturing sites located at Abbott Vascular, Inc., in Tipperary Ireland, and Synergy Health Ireland Ltd., in Offaly, Ireland.
P970003/S183 10/28/15 Real-Time	VNS Therapy System, VNS Therapy Programming Software	Cyberonics, Inc. Houston, TX 77058	Approval for the introduction of the Motion CL910 and minor modifications and enhancements to the VNS Therapy programming software Model 250 Version 11.0.4.
P970008/S065 10/29/15 180-Day	Urologix Targis System for the Treatment of BPH	Urologix, Inc. Minneapolis, MN 55447	Approval for a new manufacturing site located at Spectrum Plastics Group in Minneapolis, Minnesota.
N970012/S113 10/14/15 Special	AMS 700™ and Ambicor Inflatable Penile Prosthesis	Boston Scientific Minnetonka, MN 55343	Approval for changes in quality controls that add inspection steps to the blunt needle accessory.
P970012/S096 10/19/15 180-Day	Application Software, Kappa 400	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P970031/S050 10/21/15 Special	Freestyle Aortic Root Bioprosthesis	Medtronic Heart Valves Santa Ana, CA 92705	Approval for the addition of a precaution to instructions for use labeling.
P980016/S514 10/19/15 180-Day	Evera, GEM, Intrinsic, Marquis, Maximo, Protecta, RVLIA, Secura, Virtuoso	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P980016/S547 10/7/15 Real-Time	Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, DDBB1D1, DDBB1D4; Evera XT VR ICD Intrinsic 30 ICD, Marquis VR ICD,  Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD	Medtronic Inc. Mounds View, MN 55112	Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P980016/S548 10/29/15 180-Day	Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD	Medtronic Inc. Mounds View, MN 55112	Approval for three new alternate ICs to be used in the devices.
P980022/S140 10/2/15 135-Day	Paradigm REAL-Time System, Paradigm REAL-Time Revel System Guardian REAL-Time System, MiniLink REAL-Time System, iPro Recorder CGMS System, iPro2 Professional CGM System	Medtronic MiniMed Northridge, CA 91325	Approval for adding duplicate existing manufacturing steps to the preparation of bulk glucose oxidase (GOx) performed by the supplier for use in the sponsor’s Enlite Sensor (Model: MMT-7008) and Sof-Sensor (Models: MMT-7002 and MMT-7003) Devices. The Enlite Sensor is a component of the MiniMed 530G System. The Sof-Sensor is a component of the Paradigm REAL-Time, Paradigm REALTime Revel, Guardian REAL-Time, MiniLink REAL-Time, IPro Recorder and IPro2 Professional Continuous Glucose Monitoring systems.
P980023/S070 10/29/15 180-Day	Protego DF-1 Lead Family	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the trade name change of the currently marketed Linoxsmart Lead Family to the Protego DF-1 Lead Family.
P980035/S404 10/19/15 180-Day	Adapta, Versa, Sensia, Advisa, Application Software, AT500 DDDRP Pacing System, EnPulse, Kappa, Relia	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P980035/S437 10/7/15 Real-Time	Advisa DR IPG, Advisa SR MRI IPG	Medtronic Inc. Mounds View, MN 55112	Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P980050/S097 10/19/15 180-Day	Application Software, Jewel AF	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P990001/S119 10/19/15 180-Day	Application Software, ProVit Software, Vitatron C20, Vitatron C60, Vitatron T20, Vitatron T60	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P000053/S061 10/14/15 Special	AMS 800™ Urinary Control System	Boston Scientific Minnetonka, MN 55343	Approval for changes in quality controls that add inspection steps to the blunt needle accessory.
P010012/S399 10/2/15 Real-Time	DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D	Boston Scientific Corporation St. Paul, MN 55112	Approval for design changes to the NG3 and NG2.5 high voltage capacitors for the devices.
P010013/S066 10/27/15 Real-Time	NovaSure Impedance Controlled Endometrial Ablation System.	Hologic, Inc. Marlborough, MA 01752	Approval for software changes to the NovaSure Model 10 Radiofrequency Controller.
P010015/S255 10/19/15 180-Day	Application Software, Consulta, InSync, Syncra, Viva	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P010015/S279 10/7/15 Real-Time	Consulta CRT-P, Syncra CRT-P, Viva CRT-P	Medtronic Inc. Mounds View, MN 55112	Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P010013/S065 10/15/15 180-Day	NovaSure Impedance Controlled Endometrial Ablation System	Hologic, Inc. Marlborough, MA 01752	Approval of the following changes to the post-approval study to reflect the FDA approval of the use of transvaginal ultrasound (TVU) as an alternate confirmation test for Essure.
P010031/S478 10/19/15 180-Day	Application Software, Brava, Concerto, Consulta, InSync, Maximo II, Protecta, RV Lead Integrity Alert (RVLIA), Viva Quad	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P010031/S510 10/7/15 Real-Time	Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Concerto II CRT-D, Consulta CRT-D, InSync II Protect ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D	Medtronic Inc. Mounds View, MN 55112	Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P010031/S511 10/29/15 180-Day	Brava CRT-D, Brava CRT-D, Brava Quad CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D	Medtronic Inc. Mounds View, MN 55112	Approval for three new alternate Integrated Circuits to be used in the devices.
P020050/S024 10/15/15 Real-Time	ALLEGRETTO Wave Eye-Q Excimer Laser System	Alcon Laboratories, Inc. Fort Worth, TX 66134	Approval for labeling revisions to address design change.
P030011/S033 10/22/15 Real-Time	SynCardia temporary Total Artificial Heart (TAH-t) System	SynCardia Systems, Inc. Tucson, AZ 85713	Approval for a material change to the driveline tubing of the Freedom Driver System.
P030054/S290 10/5/15 Real-Time	Quartet Family of CRT Leads	St. Jude Medical Sylmar, CA 91342	Approval for 1458QL and 1456Q quadripolar LV leads.
P040002/S055 10/7/15 Real-Time	AFX Endovascular AAA System	Endologix, Inc. Irvine, CA 92618	Approval for changes to the AFX bifurcated delivery system.
P040003/S016 10/5/15 180-Day	ExAblate Magnetic Resonance Guided Focused Ultrasound System	Insightec Dallas, TX 75244	Approval for changes to the software of the ExAblate System including enabling movement of the transducer in the anterior and posterior direction. The modified device is referred to as the ExAblate 2100 V1.1 with software version 6.5.
P040037/S081 10/14/15 180-Day	GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface	W.L. Gore & Associates, Inc. Flagstaff, AZ 86005	Approval for a Post-Approval Study labeling update regarding revisions to the Instructions for Use to include the final study results for the RELINE Extended Follow-Up Study.
P040047/S038 10/28/15 135-Day	Coaptite Injectable Implant	Merz North America, Inc. Franksville, WI 53126	Approval for the implementation of an automated visual inspection system that replaces a manual visual inspection process.
P050007/S033 10/9/15 180-Day	StarClose SE Vascular Closure System	Abbott Vascular Temcula, CA 92591	Approval for manufacturing sites located at Abbott Vascular, Inc., in Tipperary Ireland, and Synergy Health Ireland Ltd., in Offaly Ireland.
P050033/S020 10/22/15 Special	Hydrelle	Anika Therapeutics, Incorporated Bedford, MA 01730	Approval for labeling modifications, as requested in FDA’s letter to manufacturers marketing soft tissue filler implants about the risks associated with vascular injection.
P050037/S056 10/28/15	Radiesse Dermal Filler	Merz North America, Inc. Franksville, WI 53126	Approval for the implementation of an automated visual inspection system that replaces a manual visual inspection process.
P050047/S048 10/6/15 Real-Time	Juvéderm Hyaluronate Gel Implants	Allergan Irvine, CA 92623	Approval for an improvement to the method used to measure HA content of final JUVÉDERM and VOLUMA XC products during batch release.
P050052/S062 10/28/15	Radiesse Dermal Filler	Merz North America, Inc. Franksville, WI 53126	Approval for the implementation of an automated visual inspection system that replaces a manual visual inspection process.
P060006/070 10/23/15 Real-Time	Express SD Renal Monorail Premounted Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for labeling changes regarding Magnetic Resonance Compatibility and removal of the flushing needle from the product packaging.
P060011/S007 10/15/15 135-Day	Rayner C-Flex, C-flex Aspheric, Aspheric Intraocular Lenses	Rayner Intraocular Lenses Ltd. East Sussex United Kingdom BN3 7AN	Approval for modifications to the tumbling process.
P060025/S014 10/13/15 180-Day	ATS 3f Aortic Bioprosthesis	Medtronic, Inc. Lake Forest, CA 92630	Approval of the post-approval study protocol.
P060037/S038 10/6/15 135-Day	Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee	Zimmer, Incorporated Warsaw, IN 46581	Approval for automating the final cleaning process for NexGen LPS-Flex/LPS Mobile Bearing Knee System components, and introducing a new cleaning detergent for tibial components.
P060038/S025 10/12/15 Real-Time	Mitroflow Aortic Pericardial Heart Valve	Sorin Group Canada, Inc. Burnaby, BC Canada V5J 5M1	Approval for extending the shelf life for the device from one year to two years.
P060040/S046 10/19/15 Special	Thoratec HeartMate II Left Ventricular Assist System (LVAS)	Thoratec Corporation Pleasanton, CA 94588	Approval for revisions to the Instructions for Use regarding checking the expiration date of and replacing the backup battery contained on the Pocket Controller.
P080009/S007 10/6/15 Real-Time	SEDASYS Computer-Assisted Personalized Sedation System	Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242	Approval for software changes to resolve three anomalies.
P080009/S009 10/8/15 Special	SEDASYS® Computer-Assisted Personalized Sedation System	Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242	Approval for changes to the clinical user guide/ operator’s manual to warn against the use of quaternary ammonium compound (QAC)-based disinfectants (specifically those containing ammonium chlorides). Additionally, affixing two labels to the exterior of the device which reiterate this warning.
P080026/S016 10/9/15 Real-Time	RealTime HBV	Abbott Molecular, Inc. Des Plaines, IL 60018	Approval for two changes to the application specification files to extend the chiller delay timer and change the conductivity setting for the detection of RNA Wash2 liquid.
P090012/S004 10/22/15 135-Day	Melafind	MELA Sciences Incorporated Irvington, NY 10533	Approval for a change in the cart high potential (HI-POT) breakdown test sequence and the release of hand-held imager HI-POT breakdown test procedure.
P090013/S165 10/19/15 180-Day	Revo MRI	Medtronic, Inc. Mounds View, MN 55112	Approval for the Remote Control Software on the 2090 Programmer.
P090013/S198 10/7/15 Real-Time	Revo MRI SureScan IPG	Medtronic Inc. Mounds View, MN 55112	Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P100006/S001 10/5/15 Real-Time	Augment® Bone Graft	BioMimetic Therapeutics, Inc. Franklin, TN 37067	Approval for proposed edits to the package insert.
P100017/S014 10/9/15 Real-Time	RealTime HCV	Abbott Molecular, Inc. Des Plaines, IL 60018	Approval for two changes to the application specification files to extend the chiller delay timer and change the conductivity setting for the detection of RNA Wash2 liquid.
P100022/S016 10/26/15 135-Day	Zilver® PTX® Drug-Eluting Peripheral Stent	Cook Medical Incorporated Bloomington, IN 47402	Approval for the addition of a stent reclaim process.
P100034/S013 10/5/15 Panel-Track	Optune™ (Formerly the NovoTTF-100A System)	Novocure, Ltd. Haifa, Israel	Approval for the Optune (formerly the NovoTTF-100A System). This device is indicated as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy. Optune was previously approved in 2011 for the treatment of recurrent GBM with the following Indications for Use (IFU): Optune™ is indicated following histologically-or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
P100040/S021 10/30/15 180-Day	Valiant Thoracic Stent Graft with the Captivia Delivery System	Medtronic Vascular Santa Rosa, CA 95403	Approval for an update to the Valiant Thoracic Stent Graft with Captivia Delivery System’s Instructions for Use (IFU) to include the VALOR II post approval study data.
P100041/S055 10/19/15 135-Day	Edwards SAPIEN Transcatheter Heart Valve	Edwards Lifesciences, LLC. Irvine, CA 92614	Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier.
P110002/S010 10/6/15 180-Day	Mobi-C® Cervical Disc Prosthesis	LDR Spine USA, Incorporated Austin, TX 78750	Approval for modifications to the Mobi-C labeling.
P110009/S010 10/6/15 180-Day	Mobi-C® Cervical Disc Prosthesis	LDR Spine USA, Incorporated Austin, TX 78750	Approval for modifications to the Mobi-C labeling.
P110021/S042 10/19/15 135-Day	Edwards SAPIEN Transcatheter Heart Valve	Edwards Lifesciences, LLC. Irvine, CA 92614	Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier.
P110033/S15 10/6/15 Real-Time	Juvéderm Voluma XC	Allergan Irvine, CA 92623	Approval for an improvement to the method used to measure HA content of final JUVÉDERM and VOLUMA XC products during batch release.
P120004/S001 10/16/15 180-Day	Parascript® AccuDetect® 7.0	Parascript, LLC Longmont, CO 80503	Approval for Parascript AccuDetect version 7.0.
P120010/S001 10/2/15 135-Day	MiniMed 530G System	Medtronic MiniMed Northridge, CA 91325	Approval for adding duplicate existing manufacturing steps to the preparation of bulk glucose oxidase (GOx) performed by the supplier for use in the sponsor’s Enlite Sensor (Model: MMT-7008) and Sof-Sensor (Models: MMT-7002 and MMT-7003) Devices. The Enlite Sensor is a component of the MiniMed 530G System. The Sof-Sensor is a component of the Paradigm REAL-Time, Paradigm REALTime Revel, Guardian REAL-Time, MiniLink REAL-Time, IPro Recorder and IPro2 Professional Continuous Glucose Monitoring systems.
P120010/S046 10/2/15 Panel-Track	MiniMed 530G System with Threshold Suspend featuring SmartGuard™ Technology	Medtronic, Inc. Northridge, CA 91325	Approval for the MiniMed 530G System with Threshold Suspend featuring SmartGuard technology. This device is indicated for the following: The MiniMed 530G System is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 530G System can be programmed to automatically suspend delivery of insulin when the sensor glucose value falls below a predefined threshold value. The MiniMed 530G System consists of the following devices that can be used in combination or individually: MiniMed 530G Insulin Pump, Enlite Sensor, Enlite Serter, the MiniLink Real-Time System, the Bayer Contour NextLink glucose meter, CareLink Professional Therapy Management Software for Diabetes, and CareLink Personal Therapy Management Software for Diabetes. The system requires a prescription. The MiniMed 530G System is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 530G System. The MiniMed 530G System is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm to take measures to prevent or treat hypoglycemia himself.  Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s Health Care Provider.
P120012/S009 10/9/15 Real-Time	RealTime HCV Genotype II	Abbott Molecular, Inc. Des Plaines, IL 60018	Approval for two changes to the application specification files to extend the chiller delay timer and change the conductivity setting for the detection of RNA Wash2 liquid.
P120024/S001 10/21/15 Real-Time	activL® Artificial Disc	Aesculap Implant Systems, LLC Center Valley, PA 18034	Approval for changes to the activL instrument trays.
P130006/S020 10/14/15 180-Day	GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface	W.L. Gore & Associates, Inc. Flagstaff, AZ 86005	Approval for a Post-Approval Study labeling update regarding revisions to the Instructions for Use to include the final study results for the RELINE Extended Follow-Up Study.
P130007/S003 10/30/15 135-Day	Animas Vibe System	Animas Corporation West Chester, PA 19380	Approval for a change to the manufacturing location and process for spray paint coating of the Animas Vibe insulin pump outer plastic base and cover. The Animas Vibe insulin pump is a component of the Animas Vibe System.
P130007/S008 11/3/15 Real-Time	Animas® Vibe™ System	Animas Corporation West Chester, PA 19380	Approval for replacing the flash memory of the Printed Circuit Board Assembly (PCBA) used in the Animas® VibeTM Insulin Pump, a component of the Animas® Vibe System, as well as subsequent software changes.
P130009/S004 10/19/15 135-Day	Edwards SAPIEN XT Transcatheter Heart Valve; Edwards Qualcrimp Crimping Accessory	Edwards Lifesciences, LLC. Irvine, CA 92614	Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier.
P130009/S034 10/9/15 Panel-Track	Edwards SAPIEN XT™ Transcatheter Heart Valve and Accessories, (NovaFlex+ Delivery System with Crimp Stopper and Qualcrimp Crimping Accessory Laminated or Cloth, Edwards Expandable Introducer sheath Set, Ascendra+ delivery system with crimp stopper, Ascendra+ Introducer Sheath Set, and Edwards Crimper	Edwards Lifesciences LLC Irvine, CA 92614	Approval for the SAPIEN XT Transcatheter Heart Valve, Model 9300TFX, and Accessories. This device is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).
P140018/S001 10/7/15 Real-Time	VenaSeal Closure System	Covidien Plymouth, MN 55441	Approval for the use of a single sterile barrier packaging system for the VenaSeal Closure System, in place of the double sterile barrier system

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
N18033/S079 10/15/15	VISTAKON (etafilconA) Brand Contact Lenses	Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256	Changes to the supplier of the mold material.
N970012/S112 10/30/15	AMS 700 Inflatable Penile Prosthesis	Boston Scientific, Inc. Minnetonka, MN 55343	Changes in the fabric wash process water level range, the rinse cycle pH testing, and the inspection of cut fabric angle measurement.
P830061/S122 10/2/15	Capsure and Vitatron Lead Models	Medtronic, Inc. Mounds View, MN 55112	Implementation of new serial number printing software within the existing traceability system.
P840001/S313 10/14/15	Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimulation Leads	Medtronic, Inc. Minneapolis, MN 55432	New laser welding equipment for the spinal cord stimulation (SCS) and deep brain stimulation (DBS systems).
P840001/S314 10/30/15	External Neurostimulator; Itrel 4 Programmable Neuro-stimulator for Spinal Cord Stimulation; RestorePrime Neurostimulator; PrimeAdvanced Neurostimulator; RestoreUltra Neurostimulator; RestoreAdvanced Neurostimulator; RestorSensor Neurostimulator; PrimeAdvanced SureScan MRI Neurostimulator; RestoreUltra SureScan MRI Rechargeable Neurostimulator; RestoreAdvanced SureScan MRI Rechargeable Neurostimulator; RestoreSensor SureScan MRI Rechargeable Neurostimulator	Medtronic Inc. Minneapolis, MN 55432	Update the manufacturing execution system (MES) at Medtronic Tempe Campus (MTC) in Tempe, Arizona.
P850079/S068 10/15/15	Methafilcon A and B Soft (hydrophilic) Extended Wear Contact Lenses	CooperVision, Inc. Pleasanton, CA 94588	Change in material (FINA) for the blister packaging and new supplier for this material.
P860004/S237 10/21/15	SynchroMed Infusion System	Medtronic Neuromodulation Minneapolis, MN 55432	Addition of Medtronic Puerto Rico Operations Co. in Juncos, Puerto Rico.
P860004/S238 10/30/15	SynchroMed II Infusion System	Medtronic Inc. Minneapolis, MN 55432	To update the manufacturing execution system (MES) at Medtronics hybrid supplier, Medtronic Tempe Campus (MTC) in Tempe, Arizona.
P860057/S139 10/27/15	Carpentier-Edwards PERIMOUNT Pericardial Aortic Mitral Bioprostheses	Edwards Lifesciences, LLC Irvine, CA 92614	The addition of a terminal liquid sterilization oven.
P890003/S337 10/2/15	Vitatron Brilliant S+VDD Lead	Medtronic, Inc. Mounds View, MN 55112	Implementation of new serial number printing software within the existing traceability system.
P890055/S061 10/8/15	Codman 3000 Constant-Flow Infusion Pump & MedStream Programmable Infusion System Accessories	Codman & Shurtleff, Inc. Raynham, MA 02767	Changes to the sterilization process: 1) Steam injection rate currently at 20 mbar/min will change to 5 mbar/min; 2) Gas injection rate currently at 25 mbar/min will change to 20 mbar/min; 3) Minimum primary degassing time of 10 hours will change to 8 hours; 4) The handles from the sterilization shipper, number 197548018, will be removed; 5) Add a second Ethylene Oxide (EO) Sterilization Chamber (Chamber #4; 6) A minimum EO sterilization load in Chamber #3 (existing chamber) and Chamber #4; and 7) A 2X EO sterilization for both Chamber #3 and #4.
P900056/S151 10/13/15	Rotoblator Rotational Angioplasty System Guidewire	Boston Scientific Corporation Maple Grove, MN 55311	The addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer.
P900061/S137 10/2/15	End Cap, Upsizing Sleeve	Medtronic, Inc. Mounds View, MN 55112	Implementation of new serial number printing software within the existing traceability system.
P910023/S363 10/7/15	Current+ DR, Current+ VR, Ellipse DR, Ellipse VR, Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR	St. Jude Medical Sylmar, CA 91342	Addition of an alternate feedthru supplier for high voltage capacitors utilized in the devices.
P920015/S162 10/2/15	Sprint Quattro Leads, Subcutaneous Lead, Transvene CS/SVC Lead	Medtronic, Inc. Mounds View, MN 55112	Implementation of new serial number printing software within the existing traceability system.
P920015/S165 10/30/15	Sprint Quattro Lead	Medtronic, Inc. Mounds View, MN 55112	Manufacturing transfer to a different internal supplier for the Dexamethasone Acetate (DXAC) Monolithic Controlled Release Device (MCRD) component used in the device.
P920047/S085 10/1/15	Blazer II, Blazer II HTD, Blazer Prime HTD	Boston Scientific Corporation San Jose, CA 95134	Increased capacity shipping cartons and an increased pallet configuration.
P920047/S086 10/13/15	Blazer II Cardiac Ablation Catheter and Cable	Boston Scientific Corporation Maple Grove, MN 55311	Addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer.
P930039/S137 10/2/15	SureFix Lead	Medtronic, Inc. Mounds View, MN 55112	Implementation of new serial number printing software within the existing traceability system.
P930039/S139 10/7/15	CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead	Medtronic, Inc. Mounds View, MN 55112	Welding process change, from a manual welding process to a semi-automated welding process for the Hedix Subassembly of the lead systems.
P930039/S141 10/30/15	CapSureFix Lead	Medtronic, Inc. Mounds View, MN 55112	Manufacturing transfer to a different internal supplier for the Dexamethasone Acetate (DXAC) Monolithic Controlled Release Device (MCRD) component used in the device.
P950024/S065 10/2/15	CapSure Epicardial Pacing Leads	Medtronic, Inc. Mounds View, MN 55112	Implementation of new serial number printing software within the existing traceability system.
P960004/S074 10/13/15	FINELINE II STEROX Lead Endocardial Suture Sleeve Accessory	Boston Scientific Corporation St. Paul, MN 55112	Insourcing Boston Scientific Corporation as a manufacturer for the molded silicone slit suture sleeve accessory.
P960009/S238 10/14/15	Activa Deep Brain Stimulation Therapy System	Medtronic, Inc. Minneapolis, MN 55432	New laser welding equipment for the spinal cord stimulation (SCS) and deep brain stimulation (DBS systems).
P960009/S239 10/30/15	External Neurostimulator; Activa PC Neurostimulator; Activa SC Neurostimulator; Activa RC Neurostimulator	Medtronic Inc. Minneapolis, MN 55432	Update the manufacturing execution system (MES) at Medtronic Tempe Campus (MTC) in Tempe, Arizona.
P960016/S057 10/21/15	Livewire TC Steerable Electrophysiology Catheter, Safire Bi-directional Ablation Catheter`	St. Jude Medical St. Paul, MN 55147	Remove a redundant run-in test for the Ampere system from the manufacturing process.
P960022/S011 10/19/15	Bausch & Lomb Soflens Toric (alphafilcon A) Contact Lens	Bausch & Lomb, Inc. Rochester, NY 14609	Qualifying an alternate supplier of a critical raw material component for the Bausch & Lomb Soflens Toric (alphafilcon A) contact lens.
P960040/S355 10/7/15	Incepta ICD, Energen ICD, Punctua ICD, Dynagen ICD, Inogen ICD, Origen ICD,	Boston Scientific Corporation St. Paul, MN 55112	Manufacture the spring connector block housing components for the referenced pulse generators at Boston Scientific Corporation facility, St. Paul, Minnesota.
P960040/S356 10/19/15	ORIGEN EL ICD, ORIGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD,	Boston Scientific Corporation St. Paul, MN 55112	Convert one Super Output Module (SOM) to another SOM by subjecting it to a temperature cycle screening process.
P960040/S357 10/21/15	PUNCTUA, ENERGEN, INCEPTA, ORIGEN INOGEN, DYNAGEN	Boston Scientific Corporation St. Paul, MN 55112	Eliminate an equipment check performed on equipment used to test parylene coating thickness of batteries and capacitors used in the devices.
P970004/S205 10/30/15	InterStim II Neurostimulator	Medtronic Inc. Minneapolis, MN 55432	Update the manufacturing execution system (MES) at Medtronics hybrid supplier, Medtronic Tempe Campus (MTC), Tempe, Arizona.
P970021/S043 10/2/15	GYNECARE THERMACHOICE III Uterine Balloon Therapy System	Ethicon, Inc. Somerville, NJ 08876	Changes to the manufacturing process, Process Specification For Drive Assembly, Thermachoice Catheters 3.0, for the GYNECARE THERMACHOICE Balloon Catheter.
P970051/S134 10/14/15	Nucleus CI512 and CI522 Cochlear Implant	Cochlear Americas Centennial, CO 80111	Addition of rework and inspection steps to manufacturing procedures at the Macquarie manufacturing facility.
P980003/S064 10/13/15	Chilli II Cooled Ablation Catheter and Cable	Boston Scientific Corporation Maple Grove, MN 55311	Addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer.
P980016/S549 10/14/15	Evera MRI XT DR SureScan ICD, Evera MRI XT VR SureScan ICD, Evera MRI S DR SureScan ICD, Evera MRI S VR SureScan ICD	Medtronic, Inc. Mounds View, MN 55112	Manufacturing changes: Expansion of a controlled environment area, Addition of a laser welding system, Update to hybrid tracking during manufacturing, Connector molding manufacturing process change, Addition of a soak oven temperature verification, and Implementation of a continuous monitoring system.
P980016/S552 10/23/15	Evera MRI ICD; Evera DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Maximo II ICD; Maximo II ICD; Protecta ICD; Protecta XT ICD; Secura ICD; Virtuoso II DR/VR ICD	Medtronic, Inc. Mounds View, MN 55112	Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging.
P980016/S553 10/22/15	Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Maximo II ICD; Protecta ICD; Protecta XT ICD; Secura ICD; Virtuoso II DR/VR ICD	Medtronic, Inc. Mounds View, MN 55112	Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes.
P980016/S554 10/29/15	Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD	Metronic, Inc. Mounds View, MN 55112	Change to the high voltage capacitor weld monitoring frequency.
P980035/S440 10/23/15	Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG	Medtronic, Inc. Mounds View, MN 55112	Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging.
P980035/S441 10/22/15	Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Relia IPG	Medtronic, Inc. Mounds View, MN 55112	Update the manufacturing execution system (MES) to ACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes.
P980037/S049 10/30/15	AngioJet Thrombectomy System	Boston Scientific Corporation Minneapolis, MN 55433	Change in the bioburden assessment.
P000012/S054 10/15/15	COBAS AMPLICOR Hepatitis C Virus Test version 2.0 and COBAS AmpliPrep/COBAS AMPLICOR HCV Test version 2.0	Roche Molecular Systems, Inc. Pleasanton, CA 94588	Elimination of an in-process functional test for a final component.
P000037/S043 10/5/15	On-X Prosthetic Heart Valve	On-X Life Technologies, Inc. Austin, TX 78752	The addition of a Coordinate Measuring Machine.
P010012/S400 10/7/15	Incepta ICD Energen ICD, Punctua ICD, Dynagen ICD, Inogen ICD, Origen ICD	Boston Scientific Corporation St. Paul, MN 55112	Manufacture the spring connector block housing components for the referenced pulse generators at Boston Scientific Corporation facility in St. Paul, Minnesota.
P010012/S401 10/19/15	ORIGEN CRT-D, ORIGEN X4 CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D	Boston Scientific Corporation St. Paul, MN 55112	Convert one Super Output Module (SOM) to another SOM by subjecting it to a temperature cycle screening process.
P010012/S402 10/21/15	PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN	Boston Scientific Corporation St. Paul, MN 55112	Eliminate an equipment check performed on equipment used to test parylene coating thickness of batteries and capacitors used in the device models.
P010015/S280 10/2/15	Attain Bipolar OTW Lead, Attain OTW LV Lead	Medtronic, Inc. Mounds View, MN 55112	Implementation of new serial number printing software within the existing traceability system.
P010015/S282 10/22/15	Consulta CRT-P; Syncra CRT-P; Viva CRT-P	Medtronic, Inc. Mounds View, MN 55112	Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes.
P010019/S041 10/13/15	Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended Wear (NIGHT & DAY, AIR OPTIX NIGHT & DAY AQUA, O2OPTIX, AIR OPTIX AQUA, AIR OPTIX for ASTIGMATISM, AIR OPTIX AQUA MULTIFOCAL)	Alcon Laboratories, Inc. Fort Worth, TX 76134	Introduce an alternate source of isopropyl alcohol.
P010030/S066 10/2/15	LifeVest Wearable Defibrillator-Model WCD 4000	ZOLL Manufacturing Corporation Pittsburgh, PA 15238	Alternate supplier, Sun Star, Inc., in Latrobe, Pennsylvania for the ECG backcover with retainer dual and ECG back cover with retainer single.
P010031/S514 10/22/15	Brava CRT-D; Brava Quad CRT-D; Concerto II CRT-D; Consulta CRT-D; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D	Medtronic, Inc. Mounds View, MN 55112	Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes.
P010031/S515 10/23/15	Brava CRT-D; Concerto II CRT-D; Consulta CRT-D; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D	Medtronic, Inc. Mounds View, MN 55112	Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging.
P010031/S516 10/29/15	Brava CRT-D; Brava Quad CRT-D; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D	Medtronic, Inc. Mounds View, MN 55112	Change to the high voltage capacitor weld monitoring frequency.
P010032/S101 10/15/15	Tripole, Tripole 16c, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitrode winged, Lamitrode, Penta, Quattrode, Octrode, Dual 4 Extension, Single 8 Extension, A127 Extension, 8 Channel Adapters, Compustim Adapter	St. Jude Medical Neuromodulation Plano, TX 75024	Implementation of a change to the tumbling process of electrodes used on the SCS leads, extensions, and adapters.
P020025/S079 10/1/2015	Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP	Boston Scientific Corp. San Jose, CA 95134	Increased capacity shipping cartons and an increased pallet configuration.
P020025/S080 10/13/15	Blazer II XP Cardiac Ablation Catheter and Cable	Boston Scientific Corporation Maple Grove, MN 55311	Addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer.
P020047/S063 10/22/15	Multi-Link Vision, Multi-Link Mini-Vision, and Multi-Link 8 Coronary Stent Systems	Abbott Vascular Temecula, CA 92591	Change to the stent process monitoring system.
P030011/S035 10/29/15	SynCardia temporary Total Artificial Heart (TAH-t) System	SynCardia Systems, Inc. Tucson, AZ 85713	Alternate assembler for certain Freedom Driver printed circuit board assemblies.
P030017/S236 10/9/15	Precision Spectra Spinal Cord Stimulator (SCS) System	Boston Scientific Corp. Valencia, CA 91355	Process change to the welding process for attaching the battery to the Kovar tabs on the printed circuit board assembly (PCBA) during the manufacture of Implantable Pulse Generator (IPG) devices.
P030017/S237 10/22/15	Precision Spectra Cord Stimulator (SCS) System	Boston Scientific Corporation Valencia, CA 91355	Implementation of an update to the test equipment system and associated software used for testing Continuity and HiPot on the Artisan (2X8) Surgical (Paddle) Lead and CoverEdge 32 Contact Surgical (Paddle) Leads.
P030054/S293 10/7/15	Promote+, Quadra Assura Unify, Unify Assura, Unify Quadra	St. Jude Medical Sylmar, CA 91342	Addition of an alternate feedthru supplier for high voltage capacitors utilized in the devices.
P040014/S027 10/21/15	Therapy Ablation Catheters	St. Jude Medical St. Paul, MN 55147	Remove a redundant run-in test for the Ampere system from the manufacturing process.
P040042/S032 10/21/15	Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters	St. Jude Medical St. Paul, MN 55147	Remove a redundant run-in test for the Ampere system from the manufacturing process.
P040047/042 10/1/15	COAPTITE Injectable Implant for the treatment of Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency in Adult Females	Merz North America Franksville, WI 53126	Lifting the requirement that manufacturing equipment remain dedicated to specific products.
P050037/S062 10/1/15	RADIESSE Injectable Implant	Merz North America Franksville, WI 53126	Lifting the requirement that manufacturing equipment remain dedicated to specific products.
P050047/S051 10/23/15	Juvederm Hyaluronate Gel Implants	Allergan Irvine, CA 92612	Implementation of an automated visual inspection process and accompanying in-process control for inspecting the 0.8 mL syringe configuration of Juvederm Hyaluronate Gel Implants.
P050052/S072 10/1/15	RADIESSE Injectable Implant	Merz North America Franksville, WI 53126	Lifting the requirement that manufacturing equipment remain dedicated to specific products.
P060019/S034 10/21/15	Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters	St. Jude Medical St. Paul, MN 55147	Remove a redundant run-in test for the Ampere system from the manufacturing process.
P060037/S040 10/2715	Zimmer Nexgen LPS-Flex Mobile and LPS Mobile Bearing Knee System	Zimmer, Incorporated Warsaw, IN 46581	Add a new contract laboratory to increase biological indicator verification testing capacity for the LPS mobile tibial articular surface components.
P060040/S044 10/14/15	Thoratec Heartmate II Left Ventricular Assist System (lvas)	Thoratec Corporation Pleasanton, CA 94588	Addition of an alternate supplier for a critical component in the HeartMate II LVAS Pocket Controller.
P070015/S131 10/22/15	XIENCE V and nano Everolimus Eluting Coronary Stent Systems	Abbott Vascular Inc. Temecula, CA 92589	Change to the stent process monitoring system.
P070027/S045 10/15/15	Talent Occluder with Occluder Delivery System	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Implementation of a new Internal Process Challenge Device (IPCD) inoculation method for biannual sterilization requalification.
P070027/S046 10/23/15	Talent Occluder with Occluder Delivery System	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Change in the inoculation process site for sterilization requalification.
P080006/S084 10/2/15	Attain Ability Lead	Medtronic, Inc. Mounds View, MN 55112	Implementation of new serial number printing software within the existing traceability system.
P080025/S100 10/30/15	InterStim II Neurostimulator	Medtronic Inc. Minneapolis, MN 55432	To update the manufacturing execution system (MES) at Medtronics hybrid supplier, Medtronic Tempe Campus (MTC) in Tempe, Arizona.
P080027/S021 10/15/15	OraQuick HCV Rapid Antibody Test	OraSure Technologies, Inc. Bethlehem, PA 18015	Update to weld parameters and modifications to automated welding equipment.
P090006/S016 10/20/15	Complete SE Vascular Stent System – Iliac	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Changes to the manufacturing equipment used in assembly of the Complete SE Vascular Stent System.
P090013/S199 10/2/15	CapSureFix MRI Lead Model 5086MRI	Medtronic, Inc. Mounds View, MN 55112	Implementation of new serial number printing software within the existing traceability system.
P090013/S201 10/7/15	CapSureFix MRI Lead 5086MRI	Medtronic, Inc. Mounds View, MN 55112	Welding process change, from a manual welding process to a semi-automated welding process for the Hedix Subassembly of the lead systems.
P090013/S203 10/23/15	Revo MRI SureScan IPG Model RVDR01	Medtronic, Inc. Mounds View, MN 55112	Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging.
P090013/S204 10/22/15	Revo MRI SurScan IPG	Medtronic, Inc. Mounds View, MN 55112	Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes.
P100009/S013 10/15/15	Mitraclip Clip Delivery System	Abbott Vascular, Inc. Santa Clara, CA 95054	Changes to the cleanroom classification.
P100009/S014 10/29/15	Mitraclip Clip Delivery System	Abbott Vascular, Inc. Santa Clara, CA 95054	Changes to the connector manufacturing process.
P100044/S019 10/28/15	Propel and Propel Mini Sinus Implants	Intersect ENT Menlo Park, CA 94025	Adding an incoming quality assurance test for shrinkage of the fiber components of the Propel and Propel Mini products and to increase the upper limit for the Inherent Viscosity (IV) manufacturing lot release specification to match the upper limit for the current IV design specification.
P110004/S014 10/1/15	NIRxcell CoCr Coronary Stent On Rx System	Medinol Ltd. Tel-Aviv, Israel 615801	Change to stent welding equipment.
P110006/S006 10/15/15	Invenia ABUS – Automated Breast Ultrasound System	U-Systems Inc., a GE Healthcare Company Sunnyvale, CA 94085	Changes in suppliers for 12 critical parts, to improve the parts’ quality, productivity, and delivery. The common characteristic of all 12 parts is their electrical conductivity on specified surfaces, to allow electrical continuity for proper grounding of the device. The proposed changes do not involve any changes in the design or manufacturing process of the device.
P110016/S023 10/21/15	FlexAbility Ablation Catheter	St. Jude Medical St. Paul, MN 55147	Remove a redundant run-in test for the Ampere system from the manufacturing process.
P110019/S078 10/22/15	Xience Prime Everolimus Eluting Coronary Stent System, and Xience Prime II Everolimus Eluting Coronary Stent System	Abbott Vascular Inc. Temecula, CA 92589	Change to the acceptance sampling system for dislodgement testing for the XIENCE PRIME and XIENCE PRIME II Everolimus Eluting Coronary Stent System.
P110019/S079 10/22/15	XIENCE PRIME, Xpedition, and Alpine Everolimus Eluting Coronary Stent Systems	Abbott Vascular Inc. Temecula, CA 92589	Change to the stent process monitoring system.
P110040/S008 10/20/15	Complete SE Vascular Stent System – SFA/PPA	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Changes to the manufacturing equipment used in assembly of the Complete SE Vascular Stent System.
P110042/S050 10/7/15	Emblem Subcutaneous Implantable Cardiac Defibrillator (S-ICD) Model A209	Boston Scientific Corporaton St. Paul, MN 55112	Manufacture the spring connector block housing components for the referenced pulse generators at Boston Scientific Corporation facility in St. Paul, Minnesota.
P110042/S051 10/19/15	EMBLEM S-ICD Pulse Generator	Boston Scientific Corporation St. Paul, MN 55112	Change to the radii profile measurement method for the front and back cases of the device.
P110042/S052 10/21/15	PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN	Boston Scientific Corporation St. Paul, MN 55112	Eliminate an equipment check performed on equipment used to test parylene coating thickness of batteries and capacitors used in the referenced device models.
P120005/S039 10/23/15	Dexcom G4 PLATINUM Continuous Monitoring Sysem; Dexcom G5 Mobile Continuous Glucose Monitoring System	Dexcom, Inc. San Diego, CA 92121	Removal of an in-process inspection testing performed during the manufacturing process of the G4 Platinum and G5 Mobile transmitters. The G4 PLATINUM and the G5 Mobile transmitters are components of the G4 PLATINUM Continuous Glucose Monitoring System and G5 Mobile Continuous Glucose Monitoring System, respectively.
P120017/S001 10/2/15	Myocardial Pacing	Medtronic, Inc. Mounds View, MN 55112	Implementation of new serial number printing software within the existing traceability system.
P130007/S009 10/21/15	Animas Vibe System	Animas Corporation West Chester, PA 19380	Transferring the Glucose Engine Radio Frequency Board Assembly (GE Assembly) screening testing to the supplier. The GE Assembly is a component of the Animas Vibe System.
P130009/S041 10/27/15	Edwards Sapien XT Transcatheter Heart Valve and Accessories	Edwards Lifesciences, LLC Irvine, CA 92614	The addition of a terminal liquid sterilization oven.
P130022/S001 10/2/15	Senza Spinal Cord Stimulation System	Nevro Corporation Menlo Park, CA 94025	Modification in the manufacturing process of the connector stack sub-assembly.
P130026/S010 10/21/15	TactiCath Quartz Catheter and TactiSysQuartz Equipment	St. Jude Medical St. Paul, MN 55147	Remove a redundant run-in test for the Ampere system from the manufacturing process.
P140010/S010 10/15/15	IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Automated vision inspection system.
P140015/S001 10/8/15	t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM	Tandem Diabetes Care, Inc. San Diego, CA 92121	Add a second insulin cartridge assembly production line. The insulin cartridge is a disposable component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM.
P140015/S002 10/8/15	t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM	Tandem Diabetes Care, Inc. San Diego, CA 92121	Addition of a second cartridge laser weld subassembly production line. The insulin cartridge is a disposable component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM.
P140015/S003 10/8/15	t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM	Tandem Diabetes Care, Inc. San Diego, CA 92121	Addition of a second insulin Cartridge Test System (CTS). The insulin cartridge is a disposable component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM.
P140015/S004 10/8/15	t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM	Tandem Diabetes Care, Inc. San Diego, CA 92121	Addition of a second head-to-bag insulin cartridge subassembly test system. The insulin cartridge is a disposable component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM.
P140015/S005 10/15/15	t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM	Tandem Diabetes Care, Inc. San Diego, CA 92121	Removal of a non-destructive test and a move of an existing destructive test to an earlier point in the manufacturing process of the t:slim insulin cartridge. The insulin cartridge is a disposable component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM.
P140028/S002 10/2/15	Innova Vascular Self-Expanding Stent with Delivery System	Boston Scientific Corp. Maple Grove, MN 55311	Addition of an optional oxide removal step during a manufacturing inspection.
P140028/S003 10/23/15	Innova Vascular Self-Expanding Stent With Delivery System	Boston Scientific Corporation Maple Grove, MN 55311	Equipment updates associated with the Innova stent process.

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