Medtech approvals: FDA releases November 2015 PMAs

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

Summary of PMA Originals & Supplements Approved

• Originals: 3
• Supplements: 69

Summary of PMA Originals Under Review

• Total Under Review: 57
• Total Active: 30
• Total On Hold: 27

Summary of PMA Supplements Under Review

• Total Under Review: 583
• Total Active: 433
• Total On Hold: 150

Summary of All PMA Submissions

• Originals: 4
• Supplements: 75

Summary of PMA Supplement PMA Approval/Denial Decision Times

• Number of Approvals: 69
• Number of Denials: 0
• Average Days Fr Receipt to Decision (Total Time): 193.4
• FDA Time: 103.0 Days
• MFR Time: 90.4 Days

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P130018 11/24/15	ProACT™ Adjustable Continence Therapy for Men	Uromedica, Inc. Plymouth, MN 55441	Approval for the ProACT Adjustable Continence Therapy for Men. This device is indicated for the treatment of adult men who have stress incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (TURP) and who have failed to respond adequately to conservative therapy.
P130028 11/20/15	Algovita Spinal Cord Stimulation System	Algostim, LLC Blaine, MN 55449	Approval for the Algovita Spinal Cord Stimulation System. This device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
P140019 11/3/15	i-FACTOR™ Peptide Enhanced Bone Graft	Cerapedics, Incorporated Westminster, CO 80021	Approval for the i-FACTOR Peptide Enhanced Bone Graft. This combination product is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i-FACTOR Peptide Enhanced Bone Graft P-15 Putty must be used inside an allograft bone ring and with supplemental anterior plate fixation.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P830063/S008 11/12/15 Special	Gambro Prismaflex TPE 2000 Set	Baxter Healthcare Corporation Round Lake, IL 60073	Approval for a labeling change to address complaints related to luer connector cracks.
P860003/S081 11/2/15 Real-Time	Therakos® CELLEX® Photopheresis System	Therakos, Inc. West Chester, PA 19380	Approval for the removal of the accelerometer and associated accelerometer alarm from the CELLEX instrument.
P860004/S185 11/9/15 180-Day	SynchroMed Infusion System	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for changes in manufacturing and requirements for select motor assembly components of the SynchroMed II pump.
P860004/S224 11/24/15 180-Day	Synchromed II Programmable Infusion Pump	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for two design changes: 1) Encapsulation of motor feedthroughs with medical adhesive in order to reduce system failures from feedthrough shorting; and 2) The addition of an impedance requirement to ensure electrical isolation of the motor circuit.
P910056/S019 11/19/15 135-Day	Envista® Hydrophobic Intraocular Lens	Bausch & Lomb Irvine, CA 92618	Approval for an alternate component supplier for the acrylic sheet used to mill enVista hydrophobic intraocular lens buttons (Model MX60). Specifically, the sheet manufacturing process is to alternatively transfer to the Bausch and Lomb facility in Wilmington, Massachusetts (WIL).
P910073/S122 11/6/15 180-Day	ENDOTAK RELIANCE S, ENDOTAK RELIANCE G/SG, and ENDOTAK RELIANCE DF4 Defibrillation 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; and 3) Corresponding labeling changes.
P960009/S211 11/4/15 180-Day	Activa Deep Brain Stimulation Therapy System	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for 1) expanded MRI conditions for Medtronic DBS systems; 2) updates to the Model 37651 Patient Recharger System; 3) clarifications to the guidelines for conducting CT scans on DBS patients; 4) addition of symbols to sterile and shelf-box package labels for specified models; and (5) updates to package configurations for specified models.
P960009/S229 11/17/15 180-Day	Medtronic DBS Therapy for Parkinson’s Disease	Medtronic, Inc. Minneapolis, MN 55432	Approval for a modification to the indication for use (IFU) for the Medtronic Deep Brain Stimulation (BDS) therapy for Parkinson’s disease and corresponding labeling changes associated with the IFU modification. Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson’s Disease is indicated for adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson’s disease of at least 4 years’ duration that are not adequately controlled with medication.
P960058/S116 11/24/15 180-Day	HiResolution Bionic Ear System	Advanced Bionics, LLC Valencia, CA 91355	Approval for a manufacturing site located in Valencia, California
N970003/S182 11/3/15 Real-Time	Altrua 2, Essentio, Proponent, and Accolade Pacemakers	Boston Scientific Corporation St. Paul, MN 55112	Approval for design changes to the accelerometer component and associated changes.
P970051/S131 11/19/15 135-Day	Cochlear CI500 Series Implants	Cochlear Americas Peakview Avenue Centennial, CO 80111	Approval for the manufacturing specification tolerances for three areas of the Top Shell (depth, doming in center, and flatness of chassis mating edge), a component of the implant casing.
P980016/S559 11/25/15 180-Day	Maximo II ICD, Protecta ICD , Protecta XT ICD, Virtuoso II DR/VR ICD	Medtronic, Inc. Mounds View, MN 55112	Approval for the L409 IC design and associated manufacturing changes, which is used in the devices.
P980022/S146 11/23/15 135-Day	Paradigm® REAL-Time System and Paradigm® REAL-Time Revel System	Medtronic MiniMed Northridge, CA 91325	Approval for changes in the welding process of the clear plastic window to the pump case of the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K), the Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K) and the MiniMed 530G Insulin Pump (Model: MMT-551). The Paradigm REAL-Time Insulin Pump is a part of the Paradigm REAL-Time System; the Paradigm REAL-Time Revel Insulin Pump is a part of the Paradigm REAL-Time Revel system; and the MiniMed 530G Insulin Pump is a part of the MiniMed 530G System.
P980022/S159 11/12/15 180-Day	Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REALTime, CGM System, MiniLink REAL-Time System, iPro Recorder CGM System, iPro2 Professional CGM System	Medtronic Minimed Inc. Northridge, CA 91325	Approval for an incoming receiving material specification change of a critical device component (GOx) used in the sensor fabrication process for the Enlite Sensor (MMT-7008) and Sof-Sensor (MMT-7002, MMT-7003). These sensors are components of the MiniMed 530G System and Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time CGM System, MiniLink REAL-Time System, iPro Recorder CGM System, and iPro2 Professional CGM System, respectively.
P980035/S445 11/25/15 180-Day	Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG	Medtronic, Inc. Mounds View, MN 55112	Approval for the L409 IC design and associated manufacturing changes, which is used in the devices.
P980037/S050 11/2/15 180-Day	AngioJet Rheolytic Thrombectomy System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for a manufacturing site located in Fremont, California for finished device release test, packaging and labeling.
P000006/S045 11/23/15 Real-Time	Titan Inflatable Penile Prosthesis	Coloplast Corp. Minneapolis, MN 55411	Approval for changes to the hydrophilic coating specifications and manufacturing process.
P010015/S286 11/25/15 180-Day	Consulta CRT-P, Syncra CRT-P, Viva CRT-P	Medtronic, Inc. Mounds View, MN 55112	Approval for the L409 IC design and associated manufacturing changes, which is used in the devices.
P010030/S053 11/6/15 Real-Time	Lifevest Wearable Defibrillator	Zoll Manufacturing Corporation Pittsburgh, PA 15238	Approval for the LifeVest Wearable Defibrillator 4000 and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.  The device as modified is approved for 1) Change to the length of the therapy electrode channel foam; 2) Change to the dimensional tolerances of the hole locations on the therapy electrode lidding layer; 3) Change from adhesive to crimping of the battery connector and reinforcement of the battery cells within the WCD 4000 pack; and 4) Change of material of the hex nut used in the WCD 4000 monitor electrode belt receptacle from brass to stainless steel.
P010030/S054 11/6/15 Real-Time	LifeVest® Wearable Defibrillator	Zoll Lifecor Corporation Pittsburgh, PA 15238	Approval for an alternate supplier of an off-the-shelf SDRAM integrated circuit (IC) used on the LifeVest® Wearable Defibrillator Model WCD 4000 Computer Printed Circuit Board Assemblies (PCA). The alternate supplier is Integrated Silicon Solutions Inc. (ISSI). The device, as modified, will be marketed under the trade name LifeVest Wearable Defibrillator 4000 and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
P010030/S059 11/6/15 180-Day	LifeVest® Wearable Defibrillator	Zoll Lifecor Corporation Pittsburgh, PA 15238	Approval for: 1) Redesigned ECG and Belt Node PCAs; 2) Addition of a ferrite bead to the trunk cable assembly and modification to the belt node plastic enclosure; 3) Connectorized Therapy Electrode (TE); 4) Therapy Electrode gas generator plastic enclosure inspection window; 5) Addition of an accelerometer to the front TE and additional conductors to the cable assemblies; and 6) Addition of the PTE advisory labels to the electrode belt.
P010030/S063 11/6/15 Real-Time	LifeVest Wearable Defibrillator 4000	Zoll Manufacturing Corporation Pittsburgh, PA 15238	Approval for V07.5 monitor Software which includes nine software changes to the LifeVest Wearable Defibrillator 4000 Monitor, The device, as modified, will be marketed under the trade name LifeVest Wearable Defibrillator 4000 and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
P010030/S064 11/6/15 Real-Time	LifeVest Wearable Defibrillator 4000	Zoll Manufacturing Corporation Pittsburgh, PA 15238	Approval for two electrical design changes for the LifeVest Wearable Defibrillator 4000 monitor pulse delivery circuitry. These changes include and increase the values of four DC blocking capacitors on the defibrillator PCA and two bulk capacitors on the monitor Computer/Analog (C/A) board, as well as change the DC blocking capacitor dielectric from Y5V to X7R and the addition of ferrite bead to the battery power wire on the C/A board. The device, as modified, will be marketed under the trade name LifeVest Wearable Defibrillator 4000 and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
P010031/S519 11/25/15 Real-Time	Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT- D, Protecta XT CRT-D	Medtronic, Inc. Mounds View, MN 55112	Approval for the L409 IC design and associated manufacturing changes, which is used in the devices.
P010032/S096 11/2/15 180-Day	Proclaim Neurostimulation System	St. Jude Medical Plano, TX, 75024	Approval for Proclaim Neurostimulation System.
P010032/S098 11/2/15 Real-Time	Genesis Programmer, Eon Patient Programmer, Protégé Programmer, Patient Programmer – MRI	St. Jude Medical Plano, TX 75024	Approval for an alternative resin material (C1200HF) to be used in the manufacture of the outer casing of the Genesis Programmer, Eon Patient Programmer, Protégé Programmer, Patient Programmer -MRI, and Brio Patient Programmer.
P0200036/S033 11/25/15 135-Day	S.M.A.R.T.® CONTROL® Nitinol Stent System	Cordis Corp. Fremont, CA 94555	Approval for removal of perfluoro-octanoic acid (PFOA) from the Polytetrafluoro-ethylene (PTFE) tubing.
P030005/S129 11/3/15 Real-Time	Valitude and Valitude X4 CRT-Ps	Boston Scientific Corporation St. Paul, MN 55112	Approval for design changes to the accelerometer component and associated changes.
P030011/S032 11/27/15 180-Day	SynCardia temporary Total Artificial Heart (TAH-t) System	SynCardia Systems, Inc. Tucson, AZ 85713	Approval of the following changes to the post-approval study for the device:  modification to the approved Post Approval Study for the Companion 2 Driver System, which uses the INTERMACS Registry as the data collection mechanism (INTERMACS Companion).
P030011/S034 11/2/15 Real-Time	SynCardia temporary Total Artificial Heart (TAH-t)	SynCardia Systems, Inc. Tucson, AZ 85713	Approval for a firmware upgrade to the single board computer of the Companion 2 Driver System.
P030017/S234 11/12/15 Real-Time	Precision™, Precision Spectra™, Precision Novi™ Spinal Cord Stimulator (SCS) Systems	Boston Scientific Corp. Valencia, CA 91355	Approval for a minor design change to the plug used in the distal tip of the 1×16 Infinion Leads to make the tip plug of the 1×16 Infinion lead similar to the tip plug of the Infinion CX lead.
P030023/S004 11/13/15 180-Day	OPHTEC Capsular Tension Ring, RingJect, Preloaded Single-Use Capsular Tension Ring (CTR) Injector System	Ophtec USA, Inc. Boca Raton, FL 33487	Approval to include the RingJect, a disposable injector/ delivery system designed for use with Capsular Tension Rings (CTRs), addition of the injector into the same sterile packaging process as the CTR and modification of the packaging configuration to accommodate the combined injector and the preloaded CTR. The device, as modified, will be marketed under the trade name RingJect, Model 375 and Model 376. CTRs are indicated for the stabilization of weakened, broken, or missing zonules that are suspected or observed during cataract extraction using phacoemulsification and continuous curbilinear capsulorhexis techniques in adults.
P030047/S029 11/25/15 135-Day	Synchromed II Programmable Infusion Pump	Cordis Corp. Fremont, CA 94555	Approval for removal of perfluoro-octanoic acid (PFOA) from the Polytetrafluoro-ethylene (PTFE) tubing.
P040024/S088 11/23/15 Special	Restylane-L	Galderma Laboratories L.P. Forth Worth, TX 76177	Approval for additional language in patient and provider labeling regarding the risk of intravascular injection of soft tissue fillers.
P040024/S089 11/23/15 Special	Restylane-L	Galderma Laboratories L.P. Forth Worth, TX 76177	Approval for additional language in patient and provider labeling regarding the risk of intravascular injection of soft tissue fillers.
P040047/S040 11/12/15 135-Day	Coaptite Injectable Implant	Merz North America, Inc. Franksville, WI 53126	Approval for adjustments of the standard curve range for endotoxin testing of the Coaptite and Radiesse products.
P050033/S018 11/3/15 135-Day	Hydrelle Dermal Filler	Anika Therapeutics, Incorporated Bedford, MA 01730	Approval of an alternate supplier of a material used in the manufacture Hydrelle.
P050037/S059 11/12/15 135-Day	Radiesse Injectable Implant	Merz North America, Inc. Franksville, WI 53126	Approval for adjustments of the standard curve range for endotoxin testing of the Coaptite and Radiesse products.
P050052/S065 11/12/15 135-Day	Radiesse Injectable Implant	Merz North America, Inc. Franksville, WI 53126	Approval for adjustments of the standard curve range for endotoxin testing of the Coaptite and Radiesse products.
P050052/S069 11/23/15 180-Day	Radiesse® Dermal Filler	Merz North America, Inc. Franksville, WI 53126	Approval of the post-approval study protocol.
P060038/S024 11/24/15 Real-Time	Mitroflow Aortic Pericardial Heart Valve	Sorin Group Canada, Inc. Burnaby, Canada V5J 5M1	Approval for revisions to the MRI safety labeling.
P080020/S018 11/25/15 180-Day	Gel-One®	Seikagaku Corporation Tokyo, Japan 100-0005	Approval for a change to the manufacturing and storing of Gel-One® to allow for the refrigeration (5°C ± 3°C) of in-process product (i.e. product that has not yet been packaged and labeled) for a maximum of 6 months following the date of terminal steam sterilization and prior to initiation of the product’s previously established 12 month shelf life when stored below 25°C (without freezing).
P100009/S010 11/18/15 180-Day	MitraClip Delivery System	Abbott Vascular Santa Clara, CA 95054	Approval for a manufacturing site located at Sterigenics US, LLC, in Los Angeles, California.
P100025/S009 11/23/15 180-Day	BreathTek® UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)	Otsuka America Pharmaceutical, Inc. Rockville, MD 20850	Approval for (1) a new regulatory analytical reference method for analysis of the final drug product, Pranactin-Citric, the drug component of the BreathTek UBT for H. pylori Kit (BreathTek UBT Kit); and (2) the addition of AAIPharma Services Corporation (AAIPharma) in  Wilmington, North Carolina (FEI Number 1049418) as a second analytical testing facility for Pranactin-Citric.
P100033/S004 11/12/15 135-Day	Progensa PCA3 Assay	Hologic, Inc. San Diego, CA 92121	Approval for the introduction of a new vial filler (the Capmatic Linear Bambino Filling System) at the GCD1 manufacturing facility.
P100042/S007 11/24/15 180-Day	APTIMA® HPV Assay	Hologic, Incorporated San Diego, CA 92121	Approval for a change to the Aptima HPV Assay Software from version 4.2.0 to version 4.2.1. This change is being implemented to reduce the probe reagent mixing speed in the hybridization protection assay (HPA) incubator from 14 Hz to 5 Hz on the Tigris System. The device, as modified, will be marketed under the trade name APTIMA® HPV Assay. The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens collected in ThinPrep Pap Test vials containing PresesrvCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the APTIMA HPV Assay. The assay is used with the TIGRIS DTS System or the PANTHER System.
P110027/S009 11/9/15 180-Day	therascreen KRAS RGQ PCR Kit	QIAGEN Manchester Ltd. Manchester, UK M15 6SH	Approval for a manufacturing site located at QIAGEN GmbH in Hilden, Germany.
P110035/S032 11/30/15 180-Day	Epic Vascular Nitinol Self-Expanding Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for a manufacturing site located at Boston Scientific Ireland Ltd., in Galway, Ireland.
P110038/S010 11/18/15 Special	Relay Thoracic Stent-Graft With Plus Delivery System	Bolton Medical, Inc. Sunrise, FL 33325	Approval for an additional inspection step of the release grip.
P120002/S009 11/25/15 135-Day	S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent System	Cordis Corp. Fremont, CA 94555	Approval for removal of perfluoro-octanoic acid (PFOA) from the Polytetrafluoro-ethylene (PTFE) tubing.
P120005/S038 11/6/15 Real-Time	Dexcom G4 Platinum Continuous Glucose Monitoring System	Dexcom, Inc. San Diego, CA 92121	Approval for a change in the packaging design for the sensor/ applicator for the G4 Platinum CGM System and the manufacturing line for this new packaging.
P120005/S040 11/25/15 135-Day	Dexcom G5 Mobile Continuous Glucose Monitoring System	Dexcom, Inc. San Diego, CA 92121	Approval for adding a second manufacturer for printed circuit board assemblies to be used in the Dexcom G5 transmitter and receiver.
P120010/S004 11/23/15 135-Day	MiniMed 530G System	Medtronic MiniMed Northridge, CA 91325	Approval for changes in the welding process of the clear plastic window to the pump case of the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K), the Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K) and the MiniMed 530G Insulin Pump (Model: MMT-551). The Paradigm REAL-Time Insulin Pump is a part of the Paradigm REAL-Time System; the Paradigm REAL-Time Revel Insulin Pump is a part of the Paradigm REAL-Time Revel system; and the MiniMed 530G Insulin Pump is a part of the MiniMed 530G System.
P120010/S029 11/12/15 180-Day	MiniMed 530G System	Medtronic Minimed Inc. Northridge, CA 91325	Approval for an incoming receiving material specification change of a critical device component (GOx) used in the sensor fabrication process for the Enlite Sensor (MMT-7008) and Sof-Sensor (MMT-7002, MMT-7003). These sensors are components of the MiniMed 530G System and Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time CGM System, MiniLink REAL-Time System, iPro Recorder CGM System, and iPro2 Professional CGM System, respectively.
P120019/S007 11/13/15 Panel-Track	cobas® EGFR Mutation Test v2	Roche Molecular Systems, Inc. Pleasanton, CA 94588	Approval for the cobas EGFR Mutation Test v2. This device is indicated for: The cobas EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded tumor tissue (FFPET) from non-small cell lung cancer (NSCLC) patients. The test is intended to aid in identifying patients with NSCLC whose tumors have defined EGFR mutations and for whom safety and efficacy of a drug have been established as follows: Tarceva (erlotinib)/Exon 19 deletions and L858R and Tagrisso (osimertinib) T790M.  Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas EGFR Mutation Test v2: Tarceva (erlotinib)/G719X, exon 20 insertions, T790M, S768I and L861Q/Tagrisso (osimertinib)/ G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q.  For manual sample preparation, FFPET specimens are processed using the cobas DNA Sample Preparation Kit and the cobas z 480 analyzer is used for automated amplification and detection.
P120022/S012 11/9/15 180-Day	therascreen EGFR RGQ PCR Kit	QIAGEN Manchester Ltd. Manchester, UK M15 6SH	Approval for a manufacturing site located at QIAGEN GmbH in Hilden, Germany.
P120024/S002 11/4/15 Real-Time	activL® Artificial Disc	Aesculap Implant Systems, LLC Center Valley, PA 18034	Approval for changes to the activL Artificial Disc labeling that proposed changes to the Instructions for Use, Surgical Technique, Patient Brochure, and package label to reflect the MR testing that was conducted.
P130005/S007 11/30/15 180-Day	Diamondback Orbital Atherectomy System (OAS)	Cardiovascular Systems Inc. St. Paul, MN 55112	Approval for a manufacturing site located at Cardiovascular Systems Inc., in St. Paul, Minnesota.
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 Vibe Insulin Pump, a component of the Animas Vibe System, as well as subsequent software changes.
P130021/S016 11/10/15 180-Day	Medtronic CoreValve™ System and Medtronic CoreValve™ Evolut™ R System	Medtronic CoreValve LLC Santa Rosa, CA 95403	Approval for modifying the labeling to remove the precautions regarding patients with low flow/low gradient and end-stage renal disease.
P130024/S003 11/23/15 135-Day	Lutonix Drug Coated Balloon	Lutonix, Inc. New Hope, MN 55428	Approval to change the particulate specification for the  device at lot release and stability testing.
P130024/S005 11/20/15 180-Day	Lutonix 035 Drug Coated Balloon PTA Catheter	Lutonix, Inc. New Hope, MN 55428	Approval for the addition of the 7 x 40 mm and 7 x 60 mm device sizes. The device, as modified, will be marketed under the trade name Lutonix 035 Drug Coated Balloon PTA Catheter and is indicated for percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.
P130024/S008 11/24/15 Special	Lutonix Drug Coated Balloon PTA Catheter	Lutonix, Inc. New Hope, MN 55428	Approval for changes to the Instructions for Use to provide details regarding the use of bare metal stents with the device for bailout stenting.
P130026/S009 11/17/15 Real-Time	TactiCath Quartz Set	St. Jude Medical Plymouth, MN 55442	Approval for changes to the optical sensor analyzers in the TactiCath Quartz Equipment.
P140003/S001 11/13/15 180-Day	Impella 2.5 System	Abiomed, Inc. Danvers, MA 01923	Approval of the post-approval study protocol.
P140003/S006 11/3/15 Real-Time	Impella 2.5 System	Abiomed, Inc. Danvers, MA 01923	Approval for an upgrade of the Automated Impella Controller (AIC) software to version 5.0.
P140004/S001 11/18/15 180-Day	Superion® InterSpinous Spacer (ISS)	VertiFlex®, Incorporated San Clemente, CA 92673	Approval of Post-Approval Study 1 for the device.
P140009/S002 11/2/15 Real-Time	Brio Neurostimulation System	St. Jude Medical Plano, Texas 75024	Approval for an alternative resin material (C1200HF) to be used in the manufacture of the outer casing of the Genesis Programmer, Eon Patient Programmer, Protégé Programmer, Patient Programmer -MRI, and Brio Patient Programmer.
P140020/S003 11/18/15 Real-Time	BRACAnalysis CDx™	Myriad Genetic Laboratories, Inc. Salt Lake City, UT 84108	Approval for clarifications to the intended use statement, as follows: BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with Lynparza (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located in Salt Lake City, Utah.

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
N12159/S035 11/27/15	SURGICEL Fibrillar Absorbable Hemostats	Ethicon Inc. Somerville, NJ 08876	Implement a new custom designed piece of automated cutting equipment to cut the product to its final form.
N970003/S183 11/19/15	ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE	Boston Scientific Corporation St. Paul, MN 55112	Automation of the sterile packaging process.
P790002/S033 11/6/15	Biomet EBI Bone Healing System	Zimmer Biomet Parsippany, NJ 07054	Implementation of a new solder reflow oven in the production of the printed circuit boards for the devices above.
P790005/S052 11/6/15	EBI OsteoGen Implantable Bone Growth Stimulators	Zimmer Biomet Parsippany, NJ 07054	Implementation of a new solder reflow oven in the production of the printed circuit boards for the devices above.
P790007/S046 11/4/15	Hancock Modified Orifice Valved Conduit Model	Medtronic, Inc. Santa Ana, CA 92705	The addition of three new porcine tissue suppliers.
P830055/S164 11/12/15	LCS Total Knee System	Depuy Orthopaedics, Inc. Warsaw, IN 46581	Addition of a two dimensional (2D) barcode to the distal post of the LCS Complete RP tibial knee inserts and changes to the inspection process.
P840001/S315 11/10/15	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	The update of manufacturing process changes in the surface treatment of metal piece part for the impacted implatable products (i.e., titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.
P840001/S316 11/20/15	Itrel and Restore SCS Systems	Medtronic, Inc. Minneapolis, MN 55432	Decreasing the frequency of Destructive Analysis (DA) sampling of Medium Rate batteries from once every 360/180 parts (approximately once per shift) to every 50 hours or 2400 parts ran, and the addition of FACTORYworks monitors for power and spot checks of the laser welds at Medtronic Energy and Component Center (Brooklyn Center, MN).
P850022/S026 11/6/15	Biomet OrthoPak Non-Invasive Bone Growth Stimulators & Biomet SpinalPak Non-Invasive Spine Fusion Stimulators	Zimmer Biomet Parsippany, NJ 07054	Implementation of a new solder reflow oven in the production of the printed circuit boards for the devices above.
P850035/S039 11/6/15	SpF XL IIb Implantable Spinal Fusion Stimulators & SpF-PLUS-Mini Spinal Fusion Stimulators	Zimmer Biomet Parsippany, NJ 07054	Implementation of a new solder reflow oven in the production of the printed circuit boards for the devices above.
P850079/S069 11/12/15	Frequency Xcel toric XR (methafilcon A) Soft (Hydrophilic) Extended Wear Contact Lens	CooperVision, Inc. Pleasanton, CA 94588	The transfer of Frequency Xcel toric XR (methafilcon A) Soft (Hydrophilic) Extended Wear Contact lenses manufacturing process from Dry Line S to Dry Line 1.
P860004/S239 11/4/15	Medtronic SynchroMed II Infusion System	Medtronic Neuromodulation Minneapolis, MN 55432	Relocate the supplier manufacturing facility for the rotor assembly and the finished motor component of the SynchroMed II motor, as well as replace existing equipment (laser marking equipment and tool maker’s microscope) in the motor manufacturing process.
P860004/S240 11/10/15	SynchroMed II Infusion System	Medtronic Inc. Minneapolis, MN 55432	Update of manufacturing process changes in the surface treatment of metal piece part for the impacted implantable products (i.e., titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.
P860004/S241 11/19/15	Medtronic SynchroMed II Infusion System	Medtronic Neuromodulation Minneapolis, MN 55432	Move the gear cutting process for the SynchroMed II motor gears and pumphead gear (gears 1, 2, and 3 and pump head gear used in the motor design from Hajime to Seiko where the motor gears are currently manufactured.
P860004/S242 11/20/15	SynchroMed II Infusion System	Medtronic, Inc. Minneapolis, MN 55432	Decreasing the frequency of Destructive Analysis (DA) sampling of Medium Rate batteries from once every 360/180 parts (approximately once per shift) to every 50 hours or 2400 parts ran, and the addition of FACTORYworks monitors for power and spot checks of the laser welds at Medtronic Energy and Component (Brooklyn Center, MN).
P870078/S030 11/4/15	Hancock Low Porosity Valved Conduit Model	Medtronic, Inc. Santa Ana, CA 92705	The addition of three new porcine tissue suppliers.
P890003/S340 11/4/15	MyCareLink Smart Monitor Patient Reader	Medtronic, Inc. Mounds View, MN 55112	The addition of a secondary system level test after final assembly at the supplier.
P910061/S022 11/5/15	Silicone Softport/Soflex Intraocular Lenses (IOLs)	Bausch & Lomb, Inc. Irvine, CA 92618	Changing the tensile force to break specification, adding an elongation to break specification, and adjusting the sampling plan for your haptic material.
P920015/S167 11/18/15	Sprint Quattro Lead	Medtronic, Inc. Mounds View, MN 55112	Changes to passivation process parameter settings and updates to sample sizes used for in process/final inspection at a supplier for several components of the subject lead.
P930014/S086 11/19/15	AcrySof® Single-Piece Intraocular Lenses	Alcon Laboratories, Inc. Fort Worth, TX 76134	Change to a new measurement for quality control inspection of optical performance of your AcrySof® monofocal and toric IOLs at the Ireland facility (Models SA/N60WF, SA/N60AT, SN6AT3-T5).
P930039/S143 11/18/15	CapSureFix, CapSureFix Novus, and Vitatron Crystalline Active Fixation Leads	Medtronic, Inc. Mounds View, MN 55112	Changes to passivation process parameter settings and updates to sample sizes used for in process/final inspection at a supplier for several components of the subject leads.
P950005/S059 11/5/15	Celsius DS Ablation Catheter	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of an alternate location for a plasma etching process, in addition to the qualification of a newer equipment model for that same manufacturing process.
P960009/S240 11/10/15	External Neurostimulator; Activa PC Neurostimulator; Activa SC Neurostimulator; Activa RC Neurostimulator	Medtronic Inc. Minneapolis, MN 55432	Update of manufacturing process changes in the surface treatment of metal piece part for the impacted implantable products (i.e., titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.
P960009/S241 11/20/15	Activa DBS System	Medtronic, Inc. Minneapolis, MN 55432	Decreasing the frequency of Destructive Analysis (DA) sampling of Medium Rate batteries from once every 360/180 parts (approximately once per shift) to every 50 hours or 2400 parts ran, and the addition of FACTORYworks monitors for power and spot checks of the laser welds at Medtronic Energy and Component Center (Brooklyn Center, MN).
P960016/S058 11/17/15	Livewire TC Cardiac Ablation System	St. Jude Medical St. Paul, MN 55117	Replacement of a manual measuring process with an automated measuring system.
P960040/S358 11/19/15	ORIGEN EL ICD, INOGEN EL ICD, DYNAGEN EL ICD, ORIGEN MINI ICD, INOGEN MINI ICD, DYNAGEN MINI ICD	Boston Scientific Corporation St. Paul, MN 55112	Automation of the sterile packaging process.
P970003/S186 11/20/15	Cyberonics VNS Therapy System	Cyberonics, Inc. Houston, TX 77058	Use of a new helium leak tester in the manufacturing process of pulse generators.
P970003/S187 11/25/15	VNS Therapy® System	Cyberonics, Inc. Houston, TX 77058	Addition of alternate weld parameters for the Model 303 implantable lead for the VNS Therapy® System.
P970004/S206 11/10/15	InterStim II Neurostimulator	Medtronic Inc. Minneapolis, MN 55432	Update of manufacturing process changes in the surface treatment of metal piece part for the impacted implatable products (i.e., titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.
P970004/S207 11/20/15	InterStim Therapy System	Medtronic, Inc. Minneapolis, MN 55432	Decreasing the frequency of Destructive Analysis (DA) sampling of Medium Rate batteries from once every 360/180 parts (approximately once per shift) to every 50 hours or 2400 parts ran, and the addition of FACTORYworks monitors for power and spot checks of the laser welds at Medtronic Energy and Component Center (Brooklyn Center, MN).
P970031/S051 11/4/15	Freestyle Aortic Root Bioprosthesis	Medtronic Inc. Santa Ana, CA 92705	Addition of three new porcine tissue suppliers.
P970051/S135 11/12/15	CI500 Series Cochlear Implants	Cochlear Americas Centennial, CO 80111	New supplier and a change in the upper tolerance specification of the 25 micron platinum iridium wire.
P970051/S136 11/20/15	Nucleus CI 512 and 522 Cochlear Implants	Cochlear Americas Centennial, CO 80111	Introduction of an additional cleaning step to remove primer residue prior to curing from the weld surface of the Nucleus CI 500 series implants (Nucleus CI512 and 522).
P980016/S557 11/12/15	Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuose II DR/VR ICD	Medtronic, Inc. Mounds View, MN 55112	Update to the manufacturing test software for an integrated circuit used in the devices.
P980035/S444 11/12/15	Advisa DR IPG, Advisa SR MRI IPG	Medtronic, Inc. Mounds View, MN 55112	Update to the manufacturing test software for an integrated circuit used in the devices.
P980043/S052 11/4/15	Hancock II Porcine Bioprosthesis Models	Medtronic Inc. Santa Ana, CA 92705	Addition of three new porcine tissue suppliers.
P990012/S023 11/24/15	Elecsys HBsAG Immunoassay, Elecsys HBsAG Confirmatory, and Elecsys PreciControl HBsAg	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P990025/S047 11/5/15	Navistar Ablation Catheter	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of an alternate location for a plasma etching process, in addition to the qualification of a newer equipment model for that same manufacturing process.
P990027/S020 11/5/15	Technolas 217A Excimer Laser and Technolas 217z Zyoptix Systems	Technolas Perfect Vision GmbH San Francisco, CA 94117	Replacement of the supplier of one component of your treatment card by two other suppliers.
P990056/S022 11/24/15	Elecsys Total PSA	Roche Diagnostics Indianapolis, IN 46250	Change in the testing procedure for the streptavidin-coated microparticles component used as the solid phase in Elecsys immunoassays.
P990064/S061 11/4/15	Mosaic Porcine Bioprosthesis Models	Medtronic Inc. Santa Ana, CA 92705	Addition of three new porcine tissue suppliers.
P990075/S034 11/20/15	Spectrum and Saline Breast Implants	Mentor Worldwide LLC. Somerville, NJ 08876	Changes in the manufacturing process of the primary packaging equipment, and defect classification of the primary packaging visual inspection procedure.
P000013/S012 11/5/15	Trident Ceramic-on-Ceramic Acetabular System	Howmedica Osteonics Corp. Mahwah, NJ 07430	Addition of a Co-ordinate Measuring Machine (CMM).
P000027/S021 11/24/15	Elecsys Freee PSA	Roche Diagnostics Indianapolis, IN 46250	Change in the testing procedure for the streptavidin-coated microparticles component used as the solid phase in Elecsys immunoassays.
P000044/S033 11/20/15	VITROS® Immunodiagnostic Products HBsAg Reagent Pack, VITROS® Immunodiagnostic Products HBsAg Confirmatory Kit, and VITROS® Immunodiagnostic	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626	Replacement of a raw material with an equivalent material and to add suppliers for the new material.
P010012/S403 11/19/15	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	Automation of the sterile packaging process.
P010014/S053 11/20/15	Oxford Partial Knee System	Biomet, Incorporated Warsaw, IN 46581	Addition of approved manufacturing coolants during production of components.
P010015/S284 11/12/15	Consulta CRT-P, Syncra CRT-P, Viva CRT-P	Medtronic, Inc. Mounds View, MN 55112	Update to the manufacturing test software for an integrated circuit used in the devices.
P010031/S518 11/12/15	Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D,Protecta XT CRT-D	Medtronic, Inc. Mounds View, MN 55112	Update to the manufacturing test software for an integrated circuit used in the devices.
P010032/S103 11/5/15	Genesis and Eon family Spinal Cord Stimulation (SCS) Systems-External Pulse Generator, 2 Port Header used with EPG	St. Jude Medical Plano, TX 75024	Implementation of updates to the test equipment and measurement techniques used during the manufacturing process of the micro HDMI connector of the SJM EPG Header Model 3032.
P010032/S104 11/6/15	Eon, EonC, Eon Mini, Protégé, Protégé MRI Systems	St. Jude Medical Plano, TX 75024	Use an alternative batch test method for endotoxin monitoring for the Genesis/Eon/EonC/Eon Mini/Protégé/Brio families of devices.
P010032/S105 11/6/15	Eon, EonC, Eon Mini, Protégé, Protégé MRI Implantable Pulse Generators (IPGs)	St. Jude Medical Plano, TX 75024	Acceptance of the addition of an alternate supplier for the Implantable Pulse Generator (IPG) Weld Level sub-assemblies.
P010054/S025 11/24/15	Elecsys Anti-HBs Immunoassay, Elecsys PreciControl Anti-HBs, and Elecsys Anti-HBS CalCheck	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P010068/S049 11/5/15	Navistar, Celsius, Celsius FLTR, and Navistar DS Ablation Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of an alternate location for a plasma etching process, in addition to the qualification of a newer equipment model for that same manufacturing process.
P020036/S035 11/5/15	Cordis S.M.A.R.T. Control Nitinol Stent System	Cordis Corporation Fremont, CA 94555	Change to the manufacturing location of your supplier for the internal packaging pouches.
P020045/S068 11/12/15	Freezor Cardiac CryoAblation Catheter, Freezor Xtra Surgical Cardiac CryoAblation Device, Freezor Max Surgical Cardiac CryoAblation Device	Medtronic Cryocath Lp Quebec, Canada H9R 5Z8	Changes to Smart Chip programming equipment and verification.
P030005/S130 11/19/15	VALITUDE, VALITUDE X4	Boston Scientific Corporation St. Paul, MN 55112	Automation of the sterile packaging process.
P030016/S028 11/17/15	Visian Implantable Collamer Lens for Myopia (micl)	Staar Surgical Co. Monrovia, CA 91016	Replacement of an instrument to measure dioptric power and image quality (MTF) at final product inspection.
P030017/S238 11/18/15	PrecisionTM, Precision SpectraTM, and Precision NoviTM Spinal Cord Stimulator (SCS) Systems	Boston Scientific Neuromodulation Valencia, CA 91355	Use of an alternate degreasing chemical during the vapor degreasing process of the set screws, end stops, and feed through blanks used in IPG headers and lead extensions.
P030017/S239 11/18/15	Precision Spinal Cord Stimulator (SCS) System	Boston Scientific Valencia, CA 91355	Use of an alternate welder used in the connector stack assembly process of your Implantable Pulse Generator.
P030017/S240 11/24/15	Precision Spectra and Precision Novi IPGs	Boston Scientific Corp. Valencia, CA 91355	Use of an updated test equipment system used for testing the Precision Spectra Remote Control used to support the Precision Spectra IPG and the FreeLink Remote Control used to support both Precision Spectra and Precision Novi IPGs.
P030026/S031 11/3/15	VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626	Change for the introduction of a new piece of manufacturing equipment to pack coated wells into reagent packs.
P030031/S071 11/5/15	Celsius ThermoCool, ThermoCool SF, Navistar ThermoCool, ThermoCool SF NAV, and ThermoCool SmartTouch Ablation Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of an alternate location for a plasma etching process, in addition to the qualification of a newer equipment model for that same manufacturing process.
P030036/S080 11/18/15	SelectSecure Lead	Medtronic, Inc. Mounds View, MN 55112	Changes to passivation process parameter settings and updates to sample sizes used for in process/final inspection at a supplier for several components of the subject lead.
P030039/S019 11/24/15	Coseal Surgical Sealant	Baxter Healthcare Corp. Round Lake, IL 60073	Change in resin used in the molding of several delivery system components.
P030053/S052 11/20/15	MemoryGel Breast Implants	Mentor Worldwide LLC. Somerville, NJ 08876	Changes in the manufacturing process of the primary packaging equipment, and defect classification of the primary packaging visual inspection procedure.
P040002/S056 11/18/15	AFX Endovascular AAA System	Endologix, Inc. Irvine, CA 92618	Alternate supplier to perform microbiological testing.
P040024/S087 11/6/15	Restylane, Restylane-L, Restylane Lyft, Restylane Silk, Perlane	Galderma Laboratories L.P. Fort Worth, TX 76177	Rebuild of the manufacturing line L3 clean rooms at Q-Med’s Facility 2 in Uppsala, Sweden.
P040036/S053 11/5/15	ThermoCool SmartTouch Ablation Catheter	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of an alternate location for a plasma etching process, in addition to the qualification of a newer equipment model for that same manufacturing process.
P040045/S052 11/17/15	VISTAKON (senofilcon A) Soft Contact Lens (spherical); VISTAKON (senofilcon A) Multifocal Soft Contact Lens; VISTAKON (senofilcon A) Toric Soft Contact Lens; VISTAKON (senofilcon A) Multifocal-Toric Soft Contact Lens; VISTAKON (senofilcon A) UV Blocking Contact Lenses	Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256	Implementation of an enhancement of injection molding machine (IMM) process conditions for the VISTAKON (senofilcon A) Brand Contact Lenses.
P060028/S015 11/20/15	Memoryshape Breast Implants	Mentor Worldwide LLC. Somerville, NJ 08876	Changes in the manufacturing process of the primary packaging equipment, and defect classification of the primary packaging visual inspection procedure.
P060037/S041 11/12/15	Zimmer Nexgen LPS-Flex Mobile and LPS Mobile Bearing Knee System	Zimmer, Inc. Warsaw, IN 46581	Addition of a new material supplier.
P060037/S042 11/23/15	Zimmer NexGen® LPS-Flex Mobile and LPS Mobile Bearing Knee System	Zimmer, Incorporated Warsaw, IN 46581	Addition of a new water generator.
P060040/S045 11/3/15	Thoratec HeartMate II Left Ventricular Assist System (LVAS)	Thoratec Corporation Pleasanton, CA 94588	Modify the mold used to produce the HeartMate II Pocket Controller cases.
P080011/S039 11/6/15	Biofinity XR Toric	CooperVision, Inc. Pleasanton, CA 94588	Implementation of a new lathing process step in (Made to Order (MTO)) Production Line 1.
P080011/S040 11/6/15	Biofinity (comfilconA) Soft (hydrophilic) Contact Lenses	CooperVision, Inc. Pleasanton, CA 94588	Manufacturing change to modify the lens transfer process for the manufacture of the Biofinity (comfilcon A) toric contact lenses approved under the original PMA.
P080012/S032 11/24/15	Prometra Programmable Infusion Pump System	Flowonix Medical, Inc. Mount Olive, NJ 07828	Modify the manufacturing procedure for the Patient Therapy Controller (PTC) to reroute the PTC’s power cable within the assembly to prevent it from damage.  Additionally, update the final release test to add a “bolus test” to further verify the operation of the PTC prior to release.
P080025/S101 11/10/15	InterStim II Neurostimulator	Medtronic Inc. Minneapolis, MN 55432	Update of manufacturing process changes in the surface treatment of metal piece part for the impacted implatable products (i.e., titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.
P080025/S102 11/20/15	InterStim Therapy System	Medtronic, Inc. Minneapolis, MN 55432	Decreasing the frequency of Destructive Analysis (DA) sampling of Medium Rate batteries from once every 360/180 parts (approximately once per shift) to every 50 hours or 2400 parts ran, and the addition of FACTORYworks monitors for power and spot checks of the laser welds at Medtronic Energy and Component Center (Brooklyn Center, MN).
P090007/S013 11/24/15	Elecsys Anti-HCV Immunoassay and Elecsys PreciControl Anti-HCV for use on the cobas e 411 Immunoassay Analyzer	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P090008/S015 11/24/15	Elecsys Anti-HCV Immunoassay and Elecsys PreciControl Anti-HCV for use on the cobas e 601 and cobas e 602 Immunoassay Analyzers	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P090009/S013 11/24/15	Elecsys Anti-HCV Immunoassay and Elecsys PreciControl Anti-HCV for use on the MODULAR ANALYTICS E170 Immunoassay Analyzer	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P090013/S208 11/18/15	CapSureFix MRI Lead	Medtronic, Inc. Mounds View, MN 55112	Changes to passivation process parameter settings and updates to sample sizes used for in process/final inspection at a supplier for several components of the subject lead.
P100010/S051 11/12/15	Freezor Max Cardiac CryoAblation Device, Arctic Front Cardiac CryoAblation Catheter, Arctic Front Advance Cardiac Cryoablation Catheter	Medtronic Cryocath Lp Quebec, Canada H9R 5Z8	Changes to Smart Chip programming equipment and verification.
P100021/S050 11/24/15	Endurant Stent Graft System, Endurant II Stent Graft System	Medtronic Vascular Inc. Santa Rosa, CA 95403	Implementation of an in-process inspection using an automatic pick counter during the kitting process to inspect the picks per inch (PPI) of the recovered graft materials.
P100026/S038 11/5/15	Depth and Cortical Strip Leads for NeuroPace RNS System	NeuroPace, Inc. Mountain View, CA 94043	Use of an alternate epoxy adhesive (Epoxy Technology EPO-TEK 301 epoxy) during the manufacturing of a component for the depth and cortical strip leads.
P100031/S013 11/24/15	Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc for use on the cobas e 601, cobas e 602 and MODULAR ANALYTICS E170 Immunoassay Analyzers	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P100032/S010 11/24/15	Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc for use on the Elecsys 2010 and cobas e 411 Immunoassay Analyzers	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P100042/S009 11/9/15	Aptima HPV	Hologic, Incorporated San Diego, CA 92121	Addition of a vial filler for use in manufacturing and expansion of fill volume specifications.
P100047/S067 11/20/15	Heartware Ventricular Assist System	Heartware, Inc. Miami Lakes, FL 33014	Implementation of a visual inspection system for labels.
P110022/S014 11/24/15	Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Ant-HBc IgM on the cobas e 601 and cobas e 602	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P110025/S012 11/24/15	Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM on the MODULAR ANALYTICS E170	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P110031/S011 11/24/15	Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P110042/S053 11/4/15	Emblem Subcutaneous Implantable Debibrillator (S-ICD)	Boston Scientific Corporation St. Paul, MN 55112	Add an additional supplier for nickel foil used in the battery assembly.
P110042/S055 11/19/15	EMBLEM  S-ICD System	Boston Scientific Corporation St. Paul, MN 55112	Automation of the sterile packaging process.
P120002/S011 11/5/15	Cordis S.M.A.R.T. and S.M.A.R.T. Control Vascular Stent System	Cordis Corporation Fremont, CA 94555	Change to the manufacturing location of your supplier for the internal packaging pouches.
P120007/S007 11/9/15	Aptima HPV 16 18/45 Genotype	Hologic, Incorporated San Diego, CA 92121	Addition of a vial filler for use in manufacturing and expansion of fill volume specifications.
P120010/S073 11/18/15	MiniMed 530G System	Medtronic MiniMed Northridge, CA 91325	Use a recently approved sensor base component on MPROC (Medtronic Puerto Rico Operation Company) Enlite sensors manufacturing line, to increase the number of components (bases and caps) treated per plasma cleaning cycle and to increase post-plasma shelf life of the treated components.  The Enlite Sensor is a component of the MiniMed 530G System.
P130015/S004 11/24/15	Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P140009/S006 11/6/15	Brio Neurostimulation System	St. Jude Medical Plano, TX 75024	Use an alternative batch test method for endotoxin monitoring for the Genesis/Eon/EonC/Eon Mini/Protégé/Brio families of devices.
P140009/S007 11/6/15	Brio Implantable Pulse Generators (IPGs)	St. Jude Medical Plano, TX 75024	Acceptance of the addition of an alternate supplier for the Implantable Pulse Generator (IPG) Weld Level sub-assemblies.
P140010/S011 11/23/15	IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Use of an electronic system as an alternate to a paper-based system for determining and controlling Master Lot Records (MLRs) and sampling batches or MLRs for the purpose of lot release testing.
P140021/S001 11/24/15	Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV	Roche Diagnostics Indianapolis, IN 46250	Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P140028/S004 11/9/15	Innova Vascular Self Expanding Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Addition of equipment to your manufacturing process.
P140028/S005 11/16/15	Innova Vascular Self-Expanding Stent with Delivery System	Boston Scientific Corporation Maple Grove, MN 55311	Addition of equipment to your manufacturing process.
P140028/S006 11/30/15	Innova Vascular Self-Expanding Stent with Delivery System	Boston Scientific Maple Grove, MN 55311	Removal of stent outer diameter and length inspections for the Innova Stent System.

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