Medtech approvals: FDA releases December 2015 PMAs

The Food & Drug Administration today released a list of pre-market approvals granted in December 2015:

Summary of PMA Originals & Supplements Approved

• Originals: 2
• Supplements: 81

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: 599
• Total Active: 423
• Total On Hold: 176

Summary of All PMA Submissions

• Originals: 3
• Supplements: 92

Summary of PMA Supplement PMA Approval/Denial Decision Times

• Number of Approvals: 81
• Number of Denials: 0
• Average Days Fr Receipt to Decision (Total Time): 163.1
• FDA Time: 140.4 Days
• MFR Time: 22.7 Days

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P140030 12/17/15	Astron Peripheral Self-Expanding Nitinol Stent System	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the Astron Peripheral Self-Expanding Stent System. This device is indicated for improving luminal diameter in patients with iliac atherosclerotic lesions in vessel reference diameters between 4.3mm and 9.5mm and lesion lengths up to 105mm.
P150019 12/7/15	Paradigm Real-Time Revel System	Medtronic MiniMed Northridge, CA 91325	Approval for the Paradigm Real-Time Revel System. This device is indicated for: Paradigm REAL-Time Revel insulin pump.  The Paradigm REAL-Time Revel insulin pumps (MMT-523/MMT-723) are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.  The Paradigm REAL-Time Revel system consists of the Paradigm MMT-523/MMT-723 insulin pumps, the Enlite glucose sensor (MMT-7008), and the MiniLink Transmitter (MMT-7703). Use of the Paradigm MMT-523/MMT-723 insulin pumps with the optional sensor and transmitter components is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and older).  Enlite Sensor:  The Enlite sensor (MMT-7008) is intended for use with the Paradigm REAL-Time Revel insulin pump systems (MMT-523/MMT-723) to continuously monitor glucose levels in persons with diabetes. Glucose values provided by the Paradigm REAL-Time Revel system are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the sensor glucose readings provided by the Paradigm REAL-Time Revel system.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P810031/S055 12/22/15 Special	Sodium Hyaluronate Ophthalmic Viscoelastic Devices- Healon®, Healon GV®, Healon5® Products, Healon® Ultimate Dual Pack, and Healon Duet® Dual Pack	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Approval for changes made to the Directions for Use (DFU).
P840001/S312 12/21/15 135-Day	Itrel and Restore SCS Systems	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for changes to the H2 cathode mix process used to manufacture batteries for implantable devices.
P850064/S028 12/17/15 180-Day	Life Pulse High Frequency Ventilator	Bunnell, Inc. Salt Lake City, UT 84115	Approval to upgrade the Life Pulse High Life Pulse High Frequency Ventilator 204 and patient box 213.
P860004/S235 12/30/15 135-Day	SynchroMed® II Pumps	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for changes to the propellant test method and process control limits used during manufacturing of the SynchroMed II pump.
P860004/S236 12/21/15 135-Day	SynchroMed Infusion System	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for changes to the H2 cathode mix process used to manufacture batteries for implantable devices.
P880086/S262 12/6/15 Real-Time	Assurity, Assurity+, Endurity, Accent Family of Pacemakers	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Merlin.net MN5000 Version 7.3 Software.
P890003/S341 12/8/15 Real-Time	MyCareLink Patient Monitor	Medtronic, Inc. Mounds View, MN 55112	Approval for firmware updates to the MyCareLink patient home monitor.
P890003/S342 12/8/15 Real-Time	MyCareLink Patient Monitor	Medtronic, Inc. Mounds View, MN 55112	Approval for firmware updates to the MyCareLink patient home monitor.
P910023/S364 12/6/15 Real-Time	Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Merlin.net MN5000 Version 7.3 Software.
P930014/S085 12/4/15 Real-Time	Alcon Online Toric IOL Calculator for the Acrysof ® Toric and IQ Toric Intraocular Lenses (IOLs)	Alcon Laboratories, Inc. Fort Worth, TX 76134	Approval for the Alcon Online Toric IOL Calculator which is a modification of the Toric IOL Calculators. The device, as modified, will be marketed under the trade name Alcon Online Toric IOL Calculator for the Acrysof Toric and IQ Toric IOLs. The ACRYSOF Toric and IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.
P950005/S051 12/17/15 180-Day	Biosense Webster Cables, Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ Steer DS Catheter	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for a manufacturing site located at Sterigenics, in Los Angeles, California as an alternate sterilization site.
P950037/S151 12/21/15 180-Day	Setrox S 53 and Safio S 53 Drug Eluting Permanent Right Ventricular or Right Atrial Pacemaker Electrodes	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the ProMRI Full Body Scan ICD System.
P960009/S237 12/21/15 135- Day	Activa DBS System	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for changes to the H2 cathode mix process used to manufacture batteries for implantable devices.
P960040/S360 12/21/15 180-Day	DYNAGEN EL ICD, INOGEN EL ICD, ORIGEN EL ICD, DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD	Boston Scientific St. Paul, MN 55112	Approval for hardware modifications to the NG3 family of devices.
P960043/S091 12/31/15 180-Day	Prostar XL Percutaneous Vascular Surgical 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.
P970003/S182 12/18/15 180-Day	VNS Therapy System-Aspire Generator	Cyberonics, Inc. Houston, TX 77058	Approval for using a 2-position pre-surgical surface electrocardiograph (ECG) assessment procedure to identify implant location.
P970004/S204 12/21/15 135-Day	InterStim Therapy System	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for changes to the H2 cathode mix process used to manufacture batteries for implantable devices.
P970029/S028 12/22/15 Special	CardioGenesis TMR System	CryoLife, Inc. Kennesaw, GA 30144	Approval of updates regarding foreign material inspections, and leak testing.
P970051/S130 12/4/15 135-Day	Nucleus 24 Cochlear Implant System	Cochlear Americas Centennial, CO 80111	Approval for the addition of an alternative automated electrode pad cleaning method using laser ablation.
P980016/S556 12/8/15 Real-Time	Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/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 firmware updates to the MyCareLink patient home monitor.
P980016/S558 12/08/15 Real-Time	Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/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 firmware updates to the MyCareLink patient home monitor.
P980023/S072 12/21/15 180-Day	Linox S Drug Eluting Permanent Defibrillator Electrodes. Protego DF-1, Drug Eluting Permanent Defibrillator Electrodes	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the ProMRI Full Body Scan ICD System.
P980025/S003 12/10/15 180-Day	Logicon Caries Detector	GA Industries Rancho Palos Verdes, CA 90275	Approval for a manufacturing site located at Carestream Dental in Atlanta, Georgia.
P980035/S443 12/8/15 Real-Time	Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, EnPulse E1/E2 IPG, Kappa D/DR/SR/VDD IPG	Medtronic, Inc. Mounds View, MN 55112	pproval for firmware updates to the MyCareLink patient home monitor.
P980035/S446 12/8/15 Real-Time	Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, EnPulse E1/E2 IPG, Kappa D/DR/SR/VDD IPG	Medtronic, Inc. Mounds View, MN 55112	Approval for firmware updates to the MyCareLink patient home monitor.
P980037/S046 12/14/15 135-Day	AngioJet® Rheolytic™ Thrombectomy System	Boston Scientific Corporation Minneapolis, MN 55433	Approval for an alternate vendor.
P980037/S053 12/11/15 180-Day	AngioJet® Rheolytic™ Thrombectomy Set	Boston Scientific Corporation Maple Grove, MN, 55311	Approval for a manufacturing site located at Boston Scientific Corporation in Maple Grove, Minnesota.
P980044/S027 12/21/15 Panel-Track	VISCO-3™	Seikagaku Corporation Tokoyo, Japan 100-0005	Approval for VISCO-3. This device is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
P980046/S009 12/9/15 180-Day	Home Access® Hepatitis C CheckSM	Home Access Health Corporation Hoffman Estates, IL 60169	Approval for 1) Removal of testing with the CHIRON® RIBA® HCV 3.0 SIA (RIBA) from the laboratory protocol; 2) Reporting of repeatedly reactive specimens as “Presumptive HCV Infection”; 3) Reporting of specimens for which antibodies to the hepatitis C virus were not found as “Negative”; 4) Home Access Hepatitis C Check had previously identified either Indeterminate or Positive as the reportable result; the communication will now be the same for both types of results, namely, Presumptive HCV Infection and for the patient to consult a physician of their choice and/or re-test by nucleic acid testing (NAT) for HCV RNA or equivalent; 5) Revision of the informational brochure “Answers to Frequently Asked Questions about Hepatitis C” to exclude reference to RIBA® as part of the laboratory protocol and to modify the definition of results to reflect Presumptive HCV Infection.
P990025/S040 12/17/15 180-Day	Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for a manufacturing site located at Sterigenics, in Los Angeles, California as an alternate sterilization site.
P990071/S028 12/17/15 180-Day	RADIOFREQUENCY GENERATOR –CABLES	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for a manufacturing site located at Sterigenics, in Los Angeles, CA as an alternate sterilization site.
P000009/S063 12/21/15 180-Day	ICS 3000/Renamic Programmers (Software 1503.U)	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the ProMRI Full Body Scan ICD System.
P000014/S029 12/16/15 180-Day	VITROS® Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrators	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626	Approval for removal of antifoam from a reagent and implementation of a new well wash protocol for the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrators.
P000021/S027 12/15/15 135-Day	Dimension TPSA Flex Reagent Cartridge and Dimension Vista TPSA Flex Reagent Cartridge	Siemens Healthcare Diagnostics, Inc. Newark, DE 19714	Approval for the modified process of manufacturing the polypropylene resin used in the production of Dimension HM Reaction Vessels and the Vista LOCI Reaction Vessels.
P000025/S082 12/3/15 Real-Time	Combi 40+ Cochlear Implant System: Mi1200 SYNCRHONY Implant Magnet and Mi1200 Replacement Magnet	MED-EL Corporation Durham, NC 27713	Approval for a change to the magnet material used to manufacture the Mi1200 SYNCHRONY magnet assemblies and the Mi1200 replacement magnets. The change is intended to replace the currently used magnet material which is discontinued by the supplier.
P000058/S059 12/4/15 180-Day	INFUSE® Bone Graft/Medtronic Interbody Fusion Device	Medtronic Sofamor Danek USA, Incorporated Memphis, TN 38132	Approval for expansion of the approved indications for use of INFUSE Bone Graft to include implantation with two additional interbody fusion devices, the PERIMETER Interbody Fusion Device or the CLYDESDALE Spinal System, utilizing select open surgical procedures in conjunction with supplemental spinal fixation hardware. The device, as modified, will be marketed under the trade name INFUSE Bone Graft/ Medtronic Interbody Fusion Device and is indicated for: “spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level. Patients receiving the INFUSE Bone Graft/Medtronic Interbody Fusion Device should have had at least six months of nonoperative treatment prior to treatment with the INFUSE Bone Graft/Medtronic Interbody Fusion Device.  The following interbody devices and surgical approaches may be used with INFUSE Bone Graft: 1) The LT-CAGE Lumbar Tapered Fusion Device, implanted via an anterior open or an anterior laparoscopic approach at a single level;  2) The INTER FIX or INTER FIX RP Threaded Fusion Device, implanted via an anterior open approach at a single level; 3)  The PERIMETER Interbody Fusion Device implanted via a retroperitoneal anterior lumbar interbody fusion (ALIF) at a single level from L2-S1or an oblique lateral interbody fusion (OLIF) approach at a single level from L5-S1; and 4) The CLYDESDALE Spinal System, implanted via an OLIF approach at a single level from L2-L5.”
P010012/S405 12/21/15 180-Day	DYNAGEN CRT-D, DYNAGEN X4 CRT-, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D	Boston Scientific St. Paul, MN 55112	Approval for hardware modifications to the NG3 family of devices.
P010015/S283 12/8/15 Real-Time	Consulta CRT-P, Syncra CRT-P, Viva CRT-P	Medtronic, Inc. Mounds View, MN 55112	Approval for firmware updates to the MyCareLink patient home monitor.
P010015/S285 12/8/15 Real-Time	Consulta CRT-P, Syncra CRT-P, Viva CRT-P	Medtronic, Inc. Mounds View, MN 55112	Approval for firmware updates to the MyCareLink patient home monitor.
P010030/S056 12/17/15 Panel-Track	LifeVest Wearable Cardioverter Defibrillators	ZOLL Manufacturing Corporation Pittsburgh, PA 15238	Approval for the LifeVest Wearable Cardioverter Defibrillator, Models 3000, 3100, and 4000. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. The LifeVest system is indicated for patients under 18 years of age who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.  Patients must have a chest circumference of 26 inches (66 centimeters) or greater and a weight of 18.75 kilograms (41.3 pounds) or greater.
P010031/S517 12/8/15 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/XT CRT-D, Viva S/XT CRT-D	Medtronic, Inc. Mounds View, MN 55112	Approval for firmware updates to the MyCareLink patient home monitor.
P010031/S520 12/8/15 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/XT CRT-D, Viva S/XT CRT-D	Medtronic, Inc. Mounds View, MN 55112	Approval for firmware updates to the MyCareLink patient home monitor.
P010032/S102 12/18/15 Real-Time	Eon Charging System, Eon Mini LE Charging System, Prodigy Charging System	St. Jude Medical Plano, TX 75024	Approval for modifying the internal switch mechanism of the IPG charging device.
P010068/S040 12/17/15 180-Day	Biosense Webster cables, Celsius DS Catheter, Celsius FLTR , EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for a manufacturing site located at Sterigenics, in Los Angeles, CA as an alternate sterilization site.
P020027/S022 12/15/15 135-Day	Dimension FPSA Flex Reagent Cartridge and Dimension Vista FPSA Flex Reagent Cartridge	Siemens Healthcare Diagnostics, Inc. Newark, DE 19714	Approval for the modified process of manufacturing the polypropylene resin used in the production of Dimension HM Reaction Vessels and the Vista LOCI Reaction Vessels.
P020045/S069 12/31/15 Special	Freezor Cardiac Cryoablation Catheter, Freezor Xtra Surgical Catheter	Metronic Cryocath Lp Quebec, CANADA H9R5Z8	Approval for an additional 20X magnification inspection of the catheters’ shafts.
P030011/S036 12/9/15 Special	SynCardia temporary Total Artificial Heart (TAH-t) System – Companion 2 Driver System	SynCardia Systems, Inc. Tucson, AZ 85713	Approval for the addition of two warnings to the Companion 2 Driver System Operator Manual.
P030031/S059 12/17/15 180-Day	Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Catheter, ThermoCool SF Catheters, ThermoCool SF NAV Catheters, ThermoCool SmarTouch Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for a manufacturing site located at Sterigenics, in Los Angeles, CA as an alternate sterilization site.
P030035/S140 12/6/15 Real-Time	Anthem, Allure/RF, Allure Quadra/RF Family of CRT-Ps	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Merlin.net MN5000 Version 7.3 Software.
P030052/S017 12/29/15 135-Day	UroVysion™ Bladder Cancer Kit	Abbott Molecular, Inc. Des Plaines, IL 60018	Approval for manufacturing process changes to components of the ProbeChek Control Slides for FISH using UroVysion Bladder Cancer Kit.
P030054/S294 12/6/15 Real-Time	Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+HF, Atlas+HF/II HH/II+ HF Family of CRT-Ds	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Merlin.net MN5000 Version 7.3 Software.
P040024/S083 12/15/15 Real-Time	Restylane, Restylane-L, Perlane, Perlane-L, Restylane Silk	Galderma Laboratories L.P. Fort Worth, TX 76177	Approval for a new supplier of raw Hyaluronic Acid (HTL Biotechnology S.A.S., France).
P040033/S024 12/11/15 180-Day	Birmingham Hip Resurfacing (BHR) System	Smith & Nephew Orthopaedics Cordova, TN 38016	Approval for an update to the device labeling to include the results of the completed United Kingdom (UK) post-approval study.
P040036/S044 12/17/15 180-Day	EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Catheter, ThermoCool SmarTouch Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for a manufacturing site located at Sterigenics, in Los Angeles, California as an alternate sterilization site.
P040044/S066 12/3/15 Real-Time	MynxGrip Vascular Closure Device	Access Closure, Inc. Santa Clara, CA 95054	Approval for an extension of shelf life from one year to two years.
P050023/S087 12/21/15 180-Day	Iforia 7 DR-T, Iperia 7 DR-T, Inventra 7 DR-T and Iforia 7 VR-T DX Implantable Dual- Chamber Defibrillators. Iperia 7 VR-T DX and Inventra 7 VR-T DX Single Chamber Implantable Defibrillators	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the ProMRI Full Body Scan ICD System.
P050023/S090 12/18/15 180-Day	CardioMessenger Smart	Biotronik, Inc. Lake Oswego, OR 97035	Approval for CardioMessenger Smart Model 401831.
P050037/S063 12/11/15 Special	Radiesse, Radiesse (+)	Merz North America, Inc Franksville, WI 53126	Approval for changes in product labeling – update of adverse effects descriptions.
P050052/S074 12/11/15 Special	Radiesse, Radiesse (+)	Merz North America, Inc Franksville, WI 53126	Approval for changes in product labeling – update of adverse effects descriptions.
P070008/S063 12/21/15 180-Day	ICS 3000/Renamic Programmers (Software 1503.U)	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the ProMRI Full Body Scan ICD System.
P080012/S031 12/28/15 180-Day	Prometra Programmable Infusion Pump System	Flowonix Medical, Inc. Mt. Olive, NJ 07828	Approval of the following changes to the post-approval study for the device: a revision to allow for the use of the approved Patient Therapy Controller or PTC in the post-approval clinical study for the Prometra Implantable Programmable Pump System.
P080025/S099 12/21/15 135-Day	InterStim Therapy System	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for changes to the H2 cathode mix process used to manufacture batteries for implantable devices.
P080032/S016 12/29/15 180-Day	Alair Bronchial Thermoplasty System	Boston Scientific Corporation Marlborough, MA 01752	Approval for design change to the Alair RF Controller to replace an obsolete component that is no longer commercially available.
P090013/S206 12/8/15 Real-Time	Revo MRI SureScan IPG	Medtronic, Inc. Mounds View, MN 55112	Approval for firmware updates to the MyCareLink patient home monitor.
P090013/S207 12/8/15 Real-Time	Revo MRI SureScan IPG	Medtronic, Inc. Mounds View, MN 55112	Approval for firmware updates to the MyCareLink patient home monitor.
P090016/S018 12/11/15 Special	Belotero Balance	Merz North America, Inc. Franksville, WI 53126	Approval for changes in product labeling- update to the post-market surveillance information, further clarification regarding adverse events and information regarding treatments to postmarket surveillance section
P100041/S065 12/7/15 135-Day	SAPIEN Transcatheter Heart Valve Crimper	Edwards Lifesciences, LLC Irvine, CA 92614	Approval for modifications to the cleaning process for small and large components at the Draper facility.
P110007/S007 12/22/15 Special	Healon® EndoCoat Ophthalmic Viscosurgical Devices (OVD), (3% Sodium Hyaluronate)	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Approval for changes made to the Directions for Use (DFU) to clarify instructions for use of the finger grip.
P110016/S026 12/11/15 Special	FlexAbility Ablation Catheter	St. Jude Medical, Inc. St. Paul, MN 55117	Approval for a new manufacturing fixture, and a new in-process destructive test.
P110021/S052 12/7/15 135-Day	SAPIEN Transcatheter Heart Valve Crimper	Edwards Lifesciences, LLC Irvine, CA 92614	Approval for modifications to the cleaning process for small and large components at the Draper facility.
P120024/S003 12/17/15 180-Day	activL® Artificial Disc	Aesculap Implant Systems, LLC Center Valley, PA 18034	Approval of the following changes to the post-approval study for the device: changes to the reporting timeline and activL Surgeon Survey.
P130007/S004 12/24/15 Panel-Track	Animas Vibe System	Animas Corp. West Chester, PA 19380	Approval for the Animas Vibe System. The Animas® Vibe™ System consists of the Animas Vibe Insulin Pump paired with the Dexcom G4 Platinum CGM sensor and transmitter. The Animas Vibe Insulin Pump is intended for the continuous subcutaneous infusion of insulin for the management of insulin-requiring diabetes. It can be used solely for continuous insulin delivery or as part of the Animas Vibe System to receive and display continuous glucose measurements from the Dexcom G4 PLATINUM Sensor and Transmitter. The Animas Vibe Systems continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (age 2 and older) with diabetes, and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. CGM aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long term therapy adjustments, which may minimize these excursions. Interpretation of results from the Dexcom G4 PLATINUM Sensor and Transmitter should be based on the trends and patterns seen with several sequential readings over time. The Animas Vibe System is intended for single patient use in persons age 2 and older and requires a prescription.
P130009/S028 12/7/15 135-Day	Novaflex+ Delivery System, Ascendra+ Delivery System, Edwards Expandable Introducer Sheath Set, and Crimper	Edwards Lifesciences, LLC Irvine, CA 92614	Approval for modifications to the cleaning process for small and large components at the Draper facility.
P130022/S002 12/2/15 Real-Time	Senza Spinal Cord Stimulation (SCS) System	Nevro Corporation Menlo Park, CA 94025	Approval for minor changes in the Senza System Implantable Pulse Generator (IPG) and Trial Stimulation (TSM) firmware.
P130026/S005 12/2/15 Real-Time	TactiCath Quartz Set	St. Jude Medical Plymouth, MN 55442	Approval for a new distal tip adhesive.
P130026/S013 12/22/15 Special	TactiCath Quartz Set	St. Jude Medical Plymouth, MN 55442	Approval for additional slider race component manufacturing fixtures.
P140004/S002 12/15/15 180-Day	Superion® Interspinous Spacer (ISS)	VertiFlex®, Incorporated San Clemente, CA 92673	Approval of the post-approval study protocol.
P140004/S003 12/11/15 135-Day	Superion® InterSpinous Spacer	VertiFlex®, Incorporated San Clemente, CA 92673	Approval for a change in supplier of the following manual instruments: p/n 100-9135, p/n 100-9146, p/n 100-9136, p/n 100-9137, p/n 100-9117, p/n 100-9127, and p/n 100-9139.
P140009/S005 12/18/15 Real-Time	Brio LE Charging System	St. Jude Medical Plano, Texas 75024	Approval for modifying the internal switch mechanism of the IPG charging device.
P140010/S009 12/4/15 180-Day	IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter	Medtronic, Inc. Santa Rosa, CA 95403	Approval for a manufacturing site located at Medtronic Mexico, Tijuana, Baja CA, Mexico.
P140012/S002 12/21/15 180-Day	Reshape Integrated Dual Balloon System	ReShape Medical, Inc. San Clemente, CA 92672	Approval for 1) a new delivery catheter Gen1; 2) product packaging for the ReShape Integrated Dual Balloon System; 3) extension of the balloon and delivery catheter assembly to 24 months; and 4) a new supplier for the delivery catheter assembly (Medbio, Inc., in Grand Rapids, Michigan).

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
P790005/S053 12/17/15	EBI OsteoGen™ Implantable Bone Growth Stimulators (20μA/M & 20μA/ML, 40μA/M & 40μA/ML)	EBI, LLC, d/b/a Biomet Bone Healing Technologies Parsippany, NJ 07054	Qualify an alternate supplier for a material used in the device.
P820033/S009 12/3/15	Plasmaflo™ OP-05 W (A) Asahi Plasma Separator	Asahi Kasei Medical Co., Ltd. Chiyoda-Ku, Japan 101-8101	Add a new vendor for the brominated polycarbonate raw material in the manufacture of the components of the Plasmaflo™ OP-05 W (A) Asahi Plasma Separator.
P830055/S165 12/23/15	LCS Total Knee System	DePuy Orthopaedics, Incorporated Warsaw, IN 46581	Move from a manual to an automated inspection method and to increase the frequency of this inspection following the machine milling of a slot in the LCS Complete Modular Revision Femoral components manufactured at the DePuy International, Ltd., facility in Leeds, United Kingdom.
P830055/S166 12/15/15	LCS Total Knee System	Depuy Orthopaedics, Incorporated Warsaw, IN 46580	Change to a new dosimetry system at Steris Isomedix Services (Libertyville, Ohio).
P830061/S123 12/8/15	CapSure Sense Lead and Vitatron Crystalline Lead	Medtronic, Inc. Mounds View, MN 55112	Supplier change for a coupler component.
P830061/S124 12/16/15	CapSure Sense Lead	Medtronic, Inc. Mounds View, MN 55112	Change in environmental monitoring from manual readings to an automated software system.
P840001/S317 12/3/15	Restore, Itrel and Synergy Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lead	Medtronic Inc. Minneapolis, MN 55432	Process changes to the battery burn-in testing for the Restore battery used in the  spinal cord stimulation systems.
P840001/S318 12/23/15	Restore, Itrel and Synergy Spinal Cord Stimulator System	Medtronic, Inc. Minneapolis, MN 55432	Update of the Pull Test Sample Size and Control Limits used for special manufacturing process monitoring in alignment with the Statistical Process Control Program at Medtronic Puerto Rico Operations Company in Villalba, Puerto Rico.
P850035/S040 12/17/15	SpF®-XL IIb 2/DM Implantable Spinal Fusion Stimulators (40 uA) & SpF®-PLUS-Mini (60 uA/M) Spinal Fusion Stimulators	EBI, LLC, d/b/a Biomet Bone Healing Technologies Parsippany, NJ 07054	Qualify an alternate supplier for a material used in the device.
P880086/S264 12/7/15	Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, and Verity ADx family of pacemaker devices	St. Jude Medical Sylmar, CA 91342	Use of a mold release agent on header casting assemblies in the above devices.
P880086/S265 12/15/15	Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity Adx, Verity Adx family of Pacemaker Devices	St. Jude Medical Sylmar, CA 91342	Alternate supplier for the B connector (IS-1 connector).
P910001/S081 12/3/15	Excimer Laser Coronary Atherectomy (ELCA) Catheter	Spectranetics Corporation Colorado Springs, CO 80921	Modification to the Ethylene Oxide (EO) sterilization process.
P910001/S082 12/18/15	Excimer Laser Coronary Atherectomy (ELCA) Catheter	Spectranetics Corporation Colorado Springs, CO 80921	Change to the proximal marker band fusing process.
P910023/S366 12/15/15	Current, Ellipse, Fortify, and Fortify Assura family of ICD devices	St. Jude Medical Sylmar, CA 91342	Alternate supplier for the B connector (IS-1 connector).
P910056/S021 12/4/15	EnVista® Hydrophobic Acrylic Intraocular Lens (IOL)	Bausch & Lomb, Inc. Irvine, CA 92618	Implement a bulk extraction and hydration process for the Model MX60 IOLs.
P920047/S087 12/17/15	Blazer Prime HTD	Boston Scientific Corporation San Jose, CA 95134	Additional supplier for the steering control wire.
P930014/S087 12/31/15	AcrySof® IQ Toric IOL	Alcon Laboratories, Inc. Fort Worth, TX 76134	Alcon Laboratories Ireland Ltd., as an alternate Intraocular Lens Manufacturing facility for ACRYSOF® IQ Toric IOL (Models SN6AT6, SN6AT7, SN6AT8, SN6AT9) and the use of the Manual Wet NIMO equipment for the spherical aberration measurement manufacturing process step in place of the current Long Wet Manual Aberrometer system specifically for low diopter (6.0 – 9.5 Diopter) IQ Toric lenses.
P930039/S144 12/16/15	CapSureFix Novus Lead	Medtronic, Inc. Mounds View, MN 55112	Change in environmental monitoring from manual readings to an automated software system.
P950034/S043 12/3/15	Seprafilm Adhesion Barrier	Genzyme Corporation Framingham, MA 01701	Change in the software used to manage and print barcodes and labels for the Seprafilm Adhesion Barrier device.
P960009/S242 12/23/15	Activa Deep Brain Stimulation Therapy System	Medtronic, Inc. Minneapolis, MN 55432	Update of the Pull Test Sample Size and Control Limits used for special manufacturing process monitoring in alignment with the Statistical Process Control Program at Medtronic Puerto Rico Operations Company in Villalba, Puerto Rico.
P960040/S359 12/7/15	DYNAGEN, INOGEN, AND ORIGEN ICDs	Boston Scientific Corporation St. Paul, MN 55112	Addition of a new manufacturing inspection to verify the polarity of the discrete capacitor array component on the printed circuit board.
P960042/S052 12/3/15	Spectranetics Laser Sheaths (SLS)	Spectranetics Corporation Colorado Springs, CO 80921	Modification to the Ethylene Oxide (EO) sterilization process.
P970004/S208 12/23/15	InterStim Therapy System for Urinary Control	Medtronic, Inc. Minneapolis, MN 55432	Update of the Pull Test Sample Size and Control Limits used for special manufacturing process monitoring in alignment with the Statistical Process Control Program at Medtronic Puerto Rico Operations Company in Villalba, Puerto Rico.
P970051/S138 12/30/15	Nucleus 24 Cochlear Implant System	Cochlear Americas Centennial, CO 80111	Change to the pre-sterilization cleaning process to allow for additional devices to be cleaned prior to the sterilization cycle.
P980006/S025 12/16/15	PureVision® (Single Vision Spherical), PureVision® Toric for Astigmatism, PureVision® Multi-focal for Presbyopia, PureVision2® (Single Vision Spherical), PureVision2® Toric for Astigmatism, and PurVision2® Multi-Focal for Presbyopia	Bausch and Lomb Incorporated Rochester, NY 14609	Implementation of an alternate raw material supplier.
P980022/S182 12/3/15	Paradigm® REAL-Time System Paradigm® REAL-Time Revel System	Medtronic MiniMed Northridge, CA 91235	Use harvested motors with separated flex cables in the manufacture of Paradigm Real-Time, Paradigm Real-Time Revel, and MiniMed 530G Insulin Pumps.
P980022/S184 12/4/15	Paradigm REAL-Time Revel System Paradigm REAL-Time System	Medtronic MiniMed Northridge, CA 91325	Change from a manual to automated process of assembling the motor gearbox of the Paradigm REAL-Time Insulin Pump and Paradigm REAL-Time Revel Insulin Pump.  The Paradigm REAL-Time and Paradigm REAL-Time Revel Insulin Pumps are components of the Paradigm REAL-Time and Paradigm REAL-Time Revel Systems, respectively.
P980022/S186 12/9/15	Paradigm® REAL-Time System, Paradigm® REAL-Time Revel System	Medtronic MiniMed Northridge, CA 91235	Changes in the incoming inspection criteria for the Blue Test Plug to remove the inspection of 5 non-critical dimensions.  The Blue Test Plug is intended for use with the MiniLink Transmitter (MMT-7703) and it is an accessory of Paradigm REAL-Time, Paradigm REAL-Time Revel, and MiniMed 530G Systems.
P980022/S187 12/8/15	Paradigm REAL-Time System and Paradigm REAL-Time Revel System	Medtronic Minimed Northridge, CA 91325	Manufacturing change regarding the preparation of the Piezo component of the electronic stack assemblies within the Paradigm REAL-Time/REAL-Time REVEL and 530G System pumps; a new preparation fixture is being used to assemble the Piezo component.  The affected insulin pumps are components of the Paradigm REAL-Time/REAL-Time REVEL Systems and MiniMed 530G Systems.
P980022/S188 12/9/15	Paradigm Real-Time System, Paradigm Real-Time Revel System	Medtronic MiniMed Northridge, CA 91325	Updating the inspection specifications of the drive support disk cap of the Paradigm REAL-Time, Paradigm REAL-Time Revel and MiniMed 530G insulin pumps case surface.  The Paradigm REAL-Time, Paradigm REAL-Time Revel and MiniMed 530G insulin pumps are components of the Paradigm REAL-Time, Paradigm REAL-Time Revel and MiniMed 530G Systems.
P980022/S189 12/23/15	Paradigm Real-Time System, Paradigm Real-Time Revel System	Medtronic MiniMed Northridge, CA 91325	Transfer of two sub-assembly processes for the Paradigm REAL-Time, Paradigm REAL-Time Revel, and MiniMed 530G insulin pumps from Medtronic MiniMed in Northridge, CA to Medtronic Puerto Rico Operations Company (MPROC).  The Paradigm REAL-Time and REAL-Time Revel Insulin Pumps are components of the Paradigm REAL-Time and REAL-Time Revel Systems, respectively.  The MiniMed 530G Insulin Pump is a component of the MiniMed 530G System.
P980035/S448 12/16/15	Adapta, Versa, Sensia IPG	Medtronic, Inc. Mounds View, MN 55112	Change in environmental monitoring from manual readings to an automated software system.
P980037/S051 12/2/15	AngioJet Ultra XMI Thrombectomy Set, Spiroflex, Spiroflex Vg, Distaflex Thromobectomy Set	Boston Scientific Corporation Minneapolis, MN 55433	Establish an alternate vendor, Boston Scientific Corporation Maple Grove, for the pump sub-assembly component of the AngioJet Ultra Thrombectomy System.
P980037/S052 12/9/15	AngioJet Rheolytic Thrombectomy System	Boston Scientific Corporation Minneapolis, MN 55433	Change in vendor for the Waste Bag Sub-Assembly and the Bag Spike Sub-Assembly.
P980037/S054 12/18/15	AngioJet Rheolytic Thrombectomy System	Boston Scientific Corporation Minneapolis, MN 55433	Change to the sub-assembly manufacturing process.
P980040/S063 12/14/15	TECNIS® 1-Piece IOL, TECNIS® OptiBlue 1-Piece IOL, TECNIS® Multifocal 1-Piece IOL	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Permission to automate their manufacturing line.
P980044/S029 12/10/15	SUPARTZ FX	Seikagaku Corporation Toyko, Japan 100-0005	Sharing the facility and equipment used to manufacture SUPARTZ FX for the purpose of manufacturing of an investigational drug product.
P990046/S043 12/16/15	Open Pivot Heart Valve and Aortic Valved Graft	Medtronic, Inc. Mounds View, MN 55112	Change to the bioburden monitoring strategy and sterility verification dose monitoring.
P990046/S044 12/16/15	Open Pivot Heart Valve, Open Pivot Aortic Valved Graft	Medtronic, Inc. Santa Ana, CA 92705	Relocate the fabric vendor’s manufacturing operations to La Coitat, France.
P000025/S083 12/29/15	MED-EL Cochlear Implants: Mi1200 SYNCHRONY, Mi1000 MED-EL CONCERT and SONATA TI100; Insertion Test Device and Insertion Electrode	MED-EL Elektromedizinische Geraete GmbH Innsbruck, Tirol, Austria A-6020	Alternatives to batch testing for bacterial endotoxins and establishment of a dynamic sampling plan.
P010001/S014 12/4/15	Transcend® Hip Articulation System	CeramTec GmbH Plochingen, GERMANY 73207	Addition of one clean room class 7 for the ceramic components of the TRANSCEND Hip Articulation System.
P010012/S404 12/7/15	DYNAGEN, INOGEN, AND ORIGEN CRT-Ds	Boston Scientific Corporation St. Paul, MN 55112	Addition of a new manufacturing inspection to verify the polarity of the discrete capacitor array component on the printed circuit board.
P010019/S042 12/3/15	Lotraficon B Soft Contact Lenses for Extended Wear O2Optix™, Air Optix® Aqua, Air Optix® for Astigmatism, Air Optix® Aqua Multifocal	Alcon Research LTD. Fort Worth, TX 76134	To introduce an alternate source/ manufacturer of polypropylene molded blister shells for packaging.
P010030/S069 12/3/15	Lifevest Wearable Defibrillator	Zoll Lifecor Corporation Pittsburgh, PA 15238	Addition of a new, optional dispensing equipment used in the therapy electrode manufacturing process.
P010030/S071 12/9/15	Lifevest Wearable Defibrillator	Zoll Manufacturing Corporation Pittsburgh, PA 15238	An additional, pre-approved supplier of a custom component to be used as part of the device in consideration.
P010032/S106 12/4/15	Eon, Eon C, Eon Mini, Protégé, Protégé MRI Systems	St. Jude Medical Plano, TX 75024	Minor modification on the automated manufacturing test software for both Spinal Cord Stimulation and the Deep Brain Stimulation Implantable Pulse Generators.
P010032/S107 12/9/15	Eon Mini Implantable Pulse Generator (IPG), Protégé IPG, Protégé IPG MRI	St. Jude Medical Plano, Texas 75024	Removal of a duplicate inspection procedure and changes to minimal tolerances for batteries used in the implantable pulse generators.
P010047/S040 12/11/15	Progel™ Pleural Air Leak Sealant	Neomend, Inc. Irvine, CA 92618	Phase 1 of the cleanroom expansion plan and allow product to be built and distributed using the expanded cleanroom environment.
P010047/S041 12/17/15	Progel™ Pleural Air Leak Sealant	Neomend, Inc. Irvine, CA 92618	Alternate supplier of analytical testing services for determination of the total sodium content in bicarbonate buffer solutions.
P020004/S124 12/16/15	GORE EXCLUDER AAA Endoprosthesis	W.L.Gore & Associates, Inc. Flagstaff, AZ 86005	Implement circumferential tensile testing as a lot acceptance test for the graft component.
P020025/S081 12/17/15	Blazer Prime XP and IntellaTip MiFi XP	Boston Scientific Corporation San Jose, CA 95134	Additional supplier for the steering control wire.
P030004/S009 12/18/15	Onyx™ Liquid Embolic System and Apollo™ Onyx™ Delivery Micro Catheter	Medtronic Neurovascular Irvine, CA 92618	Addition of clarification to the Coating Procedure regarding the top coat curing time and the inclusion of an additional weighing balance to the Coating Preparation procedure for the Apollo™ Onyx™ Delivery Micro Catheter.
P030016/S029 12/10/15	Visian Implantable Collamer® Lens for Myopia (MICL)	Staar Surgical Co. Monrovia, CA 91016	Add the Getinge Autoclave as an alternate sterilizer for the Visian Lens.
P030017/S242 12/4/15	Precision® Spinal Cord Stimulator (SCS) System Precision, Precision Spectra™, and Precision Novi™	Boston Scientific Neuromodulation Valencia, CA 91355	Updates to the welding schedule for resistance welding of the distal end of splitters, adaptors, and lead extensions.
P030017/S243 12/18/15	Precision Novi Spinal Cord Stimulator (SCS) System	Boston Scientific Corporation Neuromodulation Valencia, CA 91355	Change in supplier for the 47 μH inductors.
P030022/S034 12/17/15	REFLECTION Ceramic Hip System	Smith & Nephew, Inc. Cordova, TN 38016	Addition of a new water generator.
P030027/S008 12/30/15	MicroPort Orthopedics, Inc. Ceramic TRANSCEND Articulation	MicroPort Orthopedics, Incorporated Arlington, TN 38002	Addition of CeramTech’s Marktredwitz facility for the use of the hot isostatic pressure (HIP) process.
P030035/S142 12/7/15	Anthem, Allure RF, Allure Quadra, and Allure Quadra RF family of CRT-P devices	St. Jude Medical Sylmar, CA 91342	Use of a mold release agent on header casting assemblies in the above devices.
P030035/S143 12/15/15	Anthem, Allure RF, Allure Quadra, Allure Quadra RF family of CRT-P Devices	St. Jude Medical Sylmar, CA 91342	Alternate supplier for the B connector (IS-1 connector).
P030054/S296 12/15/15	Promote, Quadra Assura, Unify, Unify Assura, Unify Quadra family of CRT-D Devices	St. Jude Medical Sylmar, CA 91342	Alternate supplier for the B connector (IS-1 connector).
P040002/S057 12/2/15	AFX Endovascular AAA System	Endologix, Inc. Irvine, CA 92618	Increase in the sterilization load configuration.
P040027/S046 12/15/15	Gore VIATORR TIPS Endoprosthesis	W.L. Gore & Associates, Inc. Phoenix, AZ 85085	Alternate manufacturing location for the graft component and alternate location for component destructive testing.
P040037/S086 12/2/15	GORE® VIABAHN® Endoprosthesis GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface	W.L. Gore & Associates, Inc. Flagstaff, AZ 86005	Addition of a next generation machine (Third Generation Automatic, Tape, Align, and Transfer (ATAT)) used in the manufacture of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface.
P040037/S087 12/2/15	GORE VIABAHN Endoprosthesis	W.L. Gore & Associates, Inc. Flagstaff, AZ 860005	Implement a process setting change for the Radio Frequency Induction Bonder machine (RF Bonder).
P040045/S053 12/10/15	Vistakon (senofilcon A) Brand Contact Lenses	Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256	Implementation of an alternate raw material process for a senofilcon A monomer components of VISTAKON (senofilcon A) Brand Contact Lenses.
P040043/S078 12/16/15	GORE TAG Thoracic Endoprosthesis	W.L. Gore & Associates, Inc. Flagstaff, AZ 86005	Implement circumferential tensile testing as a lot acceptance test for the graft component.
P050019/S022 12/17/15	Carotid Wallstent Monorail Endoprosthesis	Boston Scientific Corporation Maple Grove, MN 55311	Removal of two duplicate inspections during final catheter manufacturing.
P050019/S023 12/16/15	Carotid WALLSTENT Monorail Endoprosthesis	Boston Scientific Corporation Maple Grove, MN 55311	Modifications to the stent mount process.
P050037/S064 12/29/15	Radiesse, Radiesse (+)	Merz North America, Inc. Raleigh, NC 27615	Four changes in the manufacturing process of the calcium hydroxylapatite (CaHA) particles in Radiesse.
P050038/S027 12/2/15	Arista AH, Arista AH Flexitip/Fexitip XL/Flexitip XL-R	Davol Incorporated (Subsidiary of C.R. Bard Incorporated) Woburn, MA 01801	Changes to the Poly/Tyvek pouch packaging used in both Arista FlexiTip XL and FlexiTip XL-R.  These changes included 1) Revision to pouch sealing parameters 2) Addition of appearance criteria and revised tolerances to manufactured pouch, and 3) Implementation of a new sealer for the FlexiTip XL pouch.
P050039/S018 12/30/15	Novation Ceramic Articulation Hip System (AHS)	Exactech, Incorporated Gainesville, FL 32653	Addition of CeramTech’s Marktredwitz facility for the use of the hot isostatic pressure (HIP) process.
P050052/S075 12/29/15	Radiesse, Radiesse (+)	Merz North America, Inc. Raleigh, NC 27615	Four changes in the manufacturing process of the calcium hydroxylapatite (CaHA) particles in Radiesse.
P060001/S024 12/14/15	Protégé GPS Stent System	ev3 Endovascular, Inc. Plymouth, MN 55441	Change to the manufacturing equipment for the Protégé GPS Stent System.
P070014/S049 12/9/15	Lifestent Vascular Stent System	Bard Peripheral Vascular, Inc. Tempe, AZ 85281	New supplier for a component of the delivery system.
P070026/S032 12/10/15	Ceramax Ceramic Hip System	Depuy Orthopaedics, Inc. Warsaw, IN 46581	Change in inspection method from 100% visual inspection to 100% inspection with a pin gauge at a contract manufacturer.
P070026/S033 12/15/15	CeraMax Ceramic Hip System	Depuy Orthopaedics, Incorporated Warsaw, IN 46580	Change to a new dosimetry system at Steris Isomedix Services (Libertyville, Ohio).
P080025/S103 12/23/15	Interstim Sacral Nerve Stimulation Therapy System	Medtronic, Inc. Minneapolis, MN 55432	Update of the Pull Test Sample Size and Control Limits used for special manufacturing process monitoring in alignment with the Statistical Process Control Program at Medtronic Puerto Rico Operations Company in Villalba, Puerto Rico.
P090013/S210 12/16/15	CapSureFix MRI Lead	Medtronic, Inc. Mounds View, MN 55112	Change in environmental monitoring from manual readings to an automated software system.
P100026/S039 12/9/15	NeuroPace® RNS® System	Neuropace, Inc. Mountain View, CA 94043	Addition of a cleaning step and cleaning solution to the manufacturing process that produces the Lead Ring Marker.
P100047/S066 12/10/15	HeartWare® Ventricular Assist System	HeartWare, Inc. Miami Lakes, FL 33014	Implementation of a Connector Assembly Fixture, Connector Gluing Fixture, additional inspections during the manufacturing process and to move the continuity test to further in the manufacturing process.
P100047/S068 12/3/15	HeartWare® Ventricular Assist System	HeartWare, Inc. Miami Lakes, FL 33014	Implementation of an upgraded computer for the Co-Ordinate Measuring Machine (TS00261-01).
P100047/S069 12/15/15	HeartWare® Ventricular Assist System	HeartWare, Inc. Framingham, MA 01701	To add a supplier for a critical component, where the specifications are unchanged.
P110010/S117 12/3/15	PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	To automate the carton packaging process.
P110016/S028 12/21/15	FlexAbility Ablation Catheters	St. Jude Medical, Inc. St. Paul, MN 55117	An alternate deflection tester for final release testing.
P110023/S016 12/17/15	EverFlex Self-Expanding Peripheral Stent System	Medtronic Vascular, Inc. Plymouth, MN 55441	An alternate supplier of wire braid components for the delivery system.
P110042/S056 12/9/15	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Model A209	Boston Scientific Corporation St. Paul, MN 55112	To implement a new fixture for an electrical test and to re-position a visual inspection step to after electrical testing.
P120010/S073 12/3/15	MiniMed 530G System	Medtronic MiniMed Northridge, CA 91235	Use harvested motors with separated flex cables in the manufacture of Paradigm Real-Time, Paradigm Real-Time Revel, and MiniMed 530G Insulin Pumps.
P120010/S077 12/9/15	MiniMed 530G System	Medtronic MiniMed Northridge, CA 91235	Make changes in the incoming inspection criteria for the Blue Test Plug to remove the inspection of 5 non-critical dimensions.  The Blue Test Plug is intended for use with the MiniLink Transmitter (MMT-7703) and it is an accessory of Paradigm REAL-Time, Paradigm REAL-Time Revel, and MiniMed 530G Systems.
P120010/S078 12/8/15	MiniMed 530G System	Medtronic MiniMed Northridge, CA 91325	Manufacturing change regarding the preparation of the Piezo component of the electronic stack assemblies within the Paradigm REAL-Time/REAL-Time REVEL and 530G System pumps; a new preparation fixture is being used to assemble the Piezo component.  The affected insulin pumps are components of the Paradigm REAL-Time/REAL-Time REVEL Systems and MiniMed 530G Systems.
P120010/S079 12/9/15	MiniMed 530G System	Medtronic MiniMed Northridge, CA 91325	Updating the inspection specifications of the drive support disk cap of the Paradigm REAL-Time, Paradigm REAL-Time Revel and MiniMed 530G insulin pumps case surface.  The Paradigm REAL-Time, Paradigm REAL-Time Revel and MiniMed 530G insulin pumps are components of the Paradigm REAL-Time, Paradigm REAL-Time Revel and MiniMed 530G Systems.
P120010/S080 12/23/15	MiniMed 530G System	Medtronic MiniMed Northridge, CA 91325	Transfer of two sub-assembly processes for the Paradigm REAL-Time, Paradigm REAL-Time Revel, and MiniMed 530G insulin pumps from Medtronic MiniMed in Northridge, CA to Medtronic Puerto Rico Operations Company (MPROC).  The Paradigm REAL-Time and REAL-Time Revel Insulin Pumps are components of the Paradigm REAL-Time and REAL-Time Revel Systems, respectively.  The MiniMed 530G Insulin Pump is a component of the MiniMed 530G System.
P120016/S018 12/14/15	VASCADE Vascular Closure System	Cardiva Medical, Inc. Sunnyvale, CA 94085	Removal of the collagen compression step and incoming inspection collagen hydration test.
P120020/S012 12/16/15	Supera Peripheral Stent System	Abbott Vascular Santa Clara, CA 95054	Modifications to the welding process for the Supera Peripheral Stent System.
P130006/S025 12/2/15	GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface	W.L. Gore & Associates, Inc. Flagstaff, AZ 86005	Addition of a next generation machine (Third Generation Automatic, Tape, Align, and Transfer (ATAT)) used in the manufacture of the GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface.
P130006/S026 12/2/15	GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface	W.L. Gore & Associates, Inc. Flagstaff, AZ 86005	Implement a process setting change for the Radio Frequency Induction Bonder machine (RF Bonder).
P130009/S042 12/11/15	Ascendra+ Delivery System, Novaflex+ Delivery System, Edwards Expandable Introducer Sheath Set, Crimper, Qualcrimp Crimping Accessory	Edwards Lifesciences, LLC. Irvine, CA 92614	Addition of a new cleanroom to the Edwards Draper, Utah facility.
P130009/S043 12/21/15	Novaflex+ Delivery System	Edwards Lifesciences, LLC. Irvine, CA 92614	Change to measuring equipment used in the receiving inspection of the flex tip of the NovaFlex+ delivery system.
P130016/S013 12/30/15	Nucleus 24 Hybrid System	Cochlear Americas Centennial, CO 80111	Change to the pre-sterilization cleaning process to allow for additional devices to be cleaned prior to the sterilization cycle.
P130017/S005 12/23/15	Cologuard®	Exact Sciences Corporation Philadelphia, PA 19103	Change the following: use of software spreadsheet workbook for automated data processing in place of manual calculations of acceptance criteria for Quality Control (QC) test; revision of the upper specification limit for QC Blank Positivity for markers BTACT and ACT; relocation of the QC laboratories from the first floor to the second floor within the same facility; and relocation of the labeling and dispensing activities into other rooms on the same floor.
P130028/S001 12/18/15	Algovita Spinal Cord Stimulation System	Nuvectra™ Blaine, MN 55449	Change in supplier for the LCD module component that provides the PPC touchscreen interface.
P140009/S008 12/4/15	Brio System	St. Jude Medical Plano, TX 75024	Minor modification on the automated manufacturing test software for both Spinal Cord Stimulation and the Deep Brain Stimulation Implantable Pulse Generators.
P140009/S009 12/9/15	Brio IPG	St. Jude Medical Plano, TX 75024	Removal of a duplicate inspection procedure and changes to minimal tolerances for batteries used in the implantable pulse generators.
P140012/S004 12/31/15	Reshape Integrated Dual Balloon System, Reshape Balloon Assembly, Reshape Removal Catheter, Reshape Valve Sealant	ReShape Medical, Inc. San Clemente, CA 92672	Addition of Vesta, Inc., as a second source supplier of the balloon shell (P/N 03-0238).
P140020/S004 12/22/15	BRACAnalysis CDx™	Myriad Genetic Laboratories, Inc. Salt Lake City, UT 84108	Changes to the laboratory space layout.
P150003/S001 12/3/15	SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	To automate the carton packaging process.

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