The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015:
Summary of PMA Originals & Supplements Approved
Originals: 9
Supplements: 133
Summary of PMA Originals Under Review
Total Under Review: 58
Total Active: 32
Total On Hold: 26
Summary of PMA Supplements Under Review
Total Under Review: 597
Total Active: 433
Total On Hold: 164
Summary of All PMA Submissions
Originals: 7
Supplements: 74
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 133
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 161.5
FDA Time: 97.9 Days
MFR Time: 63.6 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P150003
10/2/15
SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary
Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System. This device is indicated for improving luminal diameter in patients with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter in lesions ≤34 mm in length.
P150013
10/2/15
PD-L1 IHC 22C3 pharmDx
Dako North America, Inc.
Carpinteria, CA 93013
Approval for the PD-L1 IHC 22C3 pharmDx. This device is indicated for the following: PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 Antibody intended for use in the detection of PD-L1protein in formalin fixed, paraffin embedded (FFPE) Non-Small Cell Lung Cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining. The specimen should be considered PD-L1 positive if TPS ≥50% of the viable tumor cells exhibit membrane staining at any intensity. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab).
P150014
10/14/15
cobas® HBV
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for the cobas HBV. This device is indicated for: cobas HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human EDTA plasma or serum of HBV-infected individuals. This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas HBV must be interpreted within the context of all relevant clinical and laboratory findings. The cobas HBV is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection.
P150015
10/14/15
cobas® HCV
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for the cobas HCV. This device is indicated for: cobas HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV antibody positive or HCV-infected individuals. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay. cobas HCV is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. cobas HCV is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay can be used to measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response. The results must be interpreted within the context of all relevant clinical and laboratory findings. cobas HCV has not been approved for use as a screening test for the presence of HCV in blood or blood products. Assay performance characteristics have been established for individuals treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other DAA combination therapies are used.
P150025
10/9/15
PD-L1 IHC 28-8 pharmDx
Dako North America, Inc.
Carpinteria, CA 93013
Approval for the PD-L1 IHC 28-8 Pharmdx. This device is indicated for the following: 1) PD-L1 IHC 28-8 pharmDx is a qualitative immunohisto-chemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48; 2) PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity; and 3) PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO (nivolumab).
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P820003/S132
10/19/15
180-Day
Symbios, Synergyst
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P850051/S082
10/19/15
180-Day
Activitrax, Legend, Micro Minix, Minix, Premier, Prevail, Vitatron
Legacy
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P860057/S127
10/19/15
135-Day
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral
Bioprostheses
Edwards Lifesciences, LLC.
Irvine, CA
92614
Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier.
P890003/S326
10/19/15
180-Day
Remote Control Software for the 2090 Programmer, Analyzer Software,
Application Software, Elite II, Elite, Lead Analysis Device, Lead Analyzer, Minuet, Preva, Prodigy, Programmer Software, SessionSync Feature, Synergyst II, Thera, Vitatron Legacy, Vitatron Visa
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P890003/S336
10/7/15
Real-Time
CareLink Express Monitor, Cardiosight Reader, CareLink Home Monitor
Medtronic Inc.
Mounds View, MN 55112
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P900061/S133
10/19/15
180-Day
Medtronic GEM ICD, Medtronic Jewel ICD, Medtronic
Jewel Plus ICD, Medtronic Micro Jewel ICD, Medtronic PCD Tachyarrhythmia Control System
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P910001/S078
10/20/15
Real-Time
CVX-300/CVX-300-P Excimer Laser System
Spectranetics, Inc.
Colorado Springs, CO
80921
Approval for a minor design change to the Anti-Reflective coating that is applied to the laser vessel windows.
P920015/S146
10/19/15
180-Day
Medtronic PCD Tachyarrhythmia Control System
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P930022/S017
10/19/15
180-Day
Legend Plus
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P960004/S059
10/8/15
180-Day
FINELINE II Sterox and Sterox EZ Endocardial Pacing Leads
Boston Scientific Corporation
St Paul, MN
55112
Approval for the following: 1) A sterilization process change from Oxyfume to 100% Ethylene Oxide; 2) Drug specification changes; 3) Labeling changes; 4) To finish remaining 3 months of Lot Release Study for passive fixation leads as non-clinical post approval study; 4) Manufacturing changes to reduce elution variation; 5) To update active fixation batch release study protocol to implement new manufacturing changes; and 6) To complete 12 month Lot Release Study as non-clinical post approval study.
P960040/S354
10/2/15
Real-Time
DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, ORIGEN EL ICD, ORIGEN
MINI ICD
Boston Scientific Corporation
St. Paul, MN
55112
Approval for design changes to the NG3 and NG2.5 high voltage capacitors for the devices.
P960043/S090
10/9/15
180-Day
Perclose ProGlide Suture-Mediated Closure System
Abbott Vascular
Temecula, CA
92591
Approval for new manufacturing sites located at Abbott Vascular, Inc., in Tipperary Ireland, and Synergy Health Ireland Ltd., in Offaly, Ireland.
P970003/S183
10/28/15
Real-Time
VNS Therapy System, VNS Therapy Programming Software
Cyberonics, Inc.
Houston, TX
77058
Approval for the introduction of the Motion CL910 and minor modifications and enhancements to the VNS Therapy programming software Model 250 Version 11.0.4.
P970008/S065
10/29/15
180-Day
Urologix Targis System for the Treatment of BPH
Urologix, Inc.
Minneapolis, MN 55447
Approval for a new manufacturing site located at Spectrum Plastics Group in Minneapolis, Minnesota.
N970012/S113
10/14/15
Special
AMS 700™ and Ambicor Inflatable Penile Prosthesis
Boston Scientific
Minnetonka, MN 55343
Approval for changes in quality controls that add inspection steps to the blunt needle accessory.
P970012/S096
10/19/15
180-Day
Application Software, Kappa 400
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P970031/S050
10/21/15
Special
Freestyle Aortic Root Bioprosthesis
Medtronic Heart Valves
Santa Ana, CA
92705
Approval for the addition of a precaution to instructions for use labeling.
P980016/S514
10/19/15
180-Day
Evera, GEM, Intrinsic, Marquis, Maximo, Protecta, RVLIA, Secura, Virtuoso
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P980016/S547
10/7/15
Real-Time
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, DDBB1D1, DDBB1D4; Evera XT VR ICD Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD
Medtronic Inc.
Mounds View, MN 55112
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P980016/S548
10/29/15
180-Day
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD
Medtronic Inc.
Mounds View, MN 55112
Approval for three new alternate ICs to be used in the devices.
P980022/S140
10/2/15
135-Day
Paradigm REAL-Time System,
Paradigm REAL-Time Revel System
Guardian REAL-Time System,
MiniLink REAL-Time System,
iPro Recorder CGMS System,
iPro2 Professional CGM System
Medtronic MiniMed
Northridge, CA 91325
Approval for adding duplicate existing manufacturing steps to the preparation of bulk glucose oxidase (GOx) performed by the supplier for use in the sponsor’s Enlite Sensor (Model: MMT-7008) and Sof-Sensor (Models: MMT-7002 and MMT-7003) Devices. The Enlite Sensor is a component of the MiniMed 530G System. The Sof-Sensor is a component of the Paradigm REAL-Time, Paradigm REALTime Revel, Guardian REAL-Time, MiniLink REAL-Time, IPro Recorder and IPro2 Professional Continuous Glucose Monitoring systems.
P980023/S070
10/29/15
180-Day
Protego DF-1 Lead Family
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the trade name change of the currently marketed Linoxsmart Lead Family to the Protego DF-1 Lead Family.
P980035/S404
10/19/15
180-Day
Adapta, Versa, Sensia, Advisa, Application Software, AT500 DDDRP Pacing System, EnPulse, Kappa, Relia
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P980035/S437
10/7/15
Real-Time
Advisa DR IPG, Advisa SR MRI IPG
Medtronic Inc.
Mounds View, MN 55112
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P980050/S097
10/19/15
180-Day
Application Software, Jewel AF
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P990001/S119
10/19/15
180-Day
Application Software, ProVit Software, Vitatron C20, Vitatron C60, Vitatron T20, Vitatron T60
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P000053/S061
10/14/15
Special
AMS 800™ Urinary Control System
Boston Scientific
Minnetonka, MN 55343
Approval for changes in quality controls that add inspection steps to the blunt needle accessory.
P010012/S399
10/2/15
Real-Time
DYNAGEN
CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4
CRT-D
Boston Scientific Corporation
St. Paul, MN
55112
Approval for design changes to the NG3 and NG2.5 high voltage capacitors for the devices.
P010013/S066
10/27/15
Real-Time
NovaSure Impedance Controlled Endometrial Ablation System.
Hologic, Inc.
Marlborough, MA 01752
Approval for software changes to the NovaSure Model 10 Radiofrequency Controller.
P010015/S255
10/19/15
180-Day
Application Software, Consulta, InSync, Syncra, Viva
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P010015/S279
10/7/15
Real-Time
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
Medtronic Inc.
Mounds View, MN 55112
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P010013/S065
10/15/15
180-Day
NovaSure Impedance Controlled Endometrial Ablation System
Hologic, Inc.
Marlborough, MA 01752
Approval of the following changes to the post-approval study to reflect the FDA approval of the use of transvaginal ultrasound (TVU) as an alternate confirmation test for Essure.
P010031/S478
10/19/15
180-Day
Application Software, Brava, Concerto, Consulta, InSync, Maximo II,
Protecta, RV Lead Integrity Alert (RVLIA), Viva Quad
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P010031/S510
10/7/15
Real-Time
Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Concerto II CRT-D, Consulta CRT-D, InSync II Protect ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic Inc.
Mounds View, MN 55112
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P010031/S511
10/29/15
180-Day
Brava CRT-D, Brava CRT-D, Brava Quad CRT-D, Brava Quad CRT-D, Viva Quad S
CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic Inc.
Mounds View, MN 55112
Approval for three new alternate Integrated Circuits to be used in the devices.
P020050/S024
10/15/15
Real-Time
ALLEGRETTO Wave Eye-Q Excimer Laser System
Alcon Laboratories, Inc.
Fort Worth, TX 66134
Approval for labeling revisions to address design change.
P030011/S033
10/22/15
Real-Time
SynCardia temporary Total Artificial Heart (TAH-t) System
SynCardia Systems, Inc.
Tucson, AZ
85713
Approval for a material change to the driveline tubing of the Freedom Driver System.
P030054/S290
10/5/15
Real-Time
Quartet Family of CRT Leads
St. Jude Medical
Sylmar, CA
91342
Approval for 1458QL and 1456Q quadripolar LV leads.
P040002/S055
10/7/15
Real-Time
AFX Endovascular AAA System
Endologix, Inc.
Irvine, CA
92618
Approval for changes to the AFX bifurcated delivery system.
P040003/S016
10/5/15
180-Day
ExAblate Magnetic Resonance Guided Focused Ultrasound System
Insightec
Dallas, TX
75244
Approval for changes to the software of the ExAblate System including enabling movement of the transducer in the anterior and posterior direction. The modified device is referred to as the ExAblate 2100 V1.1 with software version 6.5.
P040037/S081
10/14/15
180-Day
GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Approval for a Post-Approval Study labeling update regarding revisions to the Instructions for Use to include the final study results for the RELINE Extended Follow-Up Study.
P040047/S038
10/28/15
135-Day
Coaptite Injectable Implant
Merz North America, Inc.
Franksville, WI 53126
Approval for the implementation of an automated visual inspection system that replaces a manual visual inspection process.
P050007/S033
10/9/15
180-Day
StarClose SE Vascular Closure System
Abbott Vascular
Temcula, CA
92591
Approval for manufacturing sites located at Abbott Vascular, Inc., in Tipperary Ireland, and Synergy Health Ireland Ltd., in Offaly Ireland.
P050033/S020
10/22/15
Special
Hydrelle
Anika Therapeutics, Incorporated
Bedford, MA
01730
Approval for labeling modifications, as requested in FDA’s letter to manufacturers marketing soft tissue filler implants about the risks associated with vascular injection.
P050037/S056
10/28/15
Radiesse Dermal Filler
Merz North America, Inc.
Franksville, WI 53126
Approval for the implementation of an automated visual inspection system that replaces a manual visual inspection process.
P050047/S048
10/6/15
Real-Time
Juvéderm Hyaluronate Gel Implants
Allergan
Irvine, CA
92623
Approval for an improvement to the method used to measure HA content of final JUVÉDERM and VOLUMA XC products during batch release.
P050052/S062
10/28/15
Radiesse Dermal Filler
Merz North America, Inc.
Franksville, WI 53126
Approval for the implementation of an automated visual inspection system that replaces a manual visual inspection process.
P060006/070
10/23/15
Real-Time
Express SD Renal Monorail Premounted Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for labeling changes regarding Magnetic Resonance Compatibility and removal of the flushing needle from the product packaging.
P060011/S007
10/15/15
135-Day
Rayner C-Flex, C-flex Aspheric, Aspheric Intraocular Lenses
Rayner Intraocular Lenses Ltd.
East Sussex
United Kingdom
BN3 7AN
Approval for modifications to the tumbling process.
P060025/S014
10/13/15
180-Day
ATS 3f Aortic Bioprosthesis
Medtronic, Inc.
Lake Forest, CA 92630
Approval of the post-approval study protocol.
P060037/S038
10/6/15
135-Day
Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee
Zimmer, Incorporated
Warsaw, IN
46581
Approval for automating the final cleaning process for NexGen LPS-Flex/LPS Mobile Bearing Knee System components, and introducing a new cleaning detergent for tibial components.
P060038/S025
10/12/15
Real-Time
Mitroflow Aortic Pericardial Heart Valve
Sorin Group Canada, Inc.
Burnaby, BC Canada
V5J 5M1
Approval for extending the shelf life for the device from one year to two years.
P060040/S046
10/19/15
Special
Thoratec HeartMate II Left Ventricular Assist System (LVAS)
Thoratec Corporation
Pleasanton, CA 94588
Approval for revisions to the Instructions for Use regarding checking the expiration date of and replacing the backup battery contained on the Pocket Controller.
P080009/S007
10/6/15
Real-Time
SEDASYS Computer-Assisted Personalized Sedation System
Ethicon Endo-Surgery, Inc.
Cincinnati, OH 45242
Approval for software changes to resolve three anomalies.
P080009/S009
10/8/15
Special
SEDASYS® Computer-Assisted Personalized Sedation System
Ethicon Endo-Surgery, Inc.
Cincinnati, OH 45242
Approval for changes to the clinical user guide/ operator’s manual to warn against the use of quaternary ammonium compound (QAC)-based disinfectants (specifically those containing ammonium chlorides). Additionally, affixing two labels to the exterior of the device which reiterate this warning.
P080026/S016
10/9/15
Real-Time
RealTime HBV
Abbott Molecular, Inc.
Des Plaines, IL 60018
Approval for two changes to the application specification files to extend the chiller delay timer and change the conductivity setting for the detection of RNA Wash2 liquid.
P090012/S004
10/22/15
135-Day
Melafind
MELA Sciences Incorporated
Irvington, NY 10533
Approval for a change in the cart high potential (HI-POT) breakdown test sequence and the release of hand-held imager HI-POT breakdown test procedure.
P090013/S165
10/19/15
180-Day
Revo MRI
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Remote Control Software on the 2090 Programmer.
P090013/S198
10/7/15
Real-Time
Revo MRI SureScan IPG
Medtronic Inc.
Mounds View, MN 55112
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices.
P100006/S001
10/5/15
Real-Time
Augment® Bone Graft
BioMimetic Therapeutics, Inc.
Franklin, TN
37067
Approval for proposed edits to the package insert.
P100017/S014
10/9/15
Real-Time
RealTime HCV
Abbott Molecular, Inc.
Des Plaines, IL 60018
Approval for two changes to the application specification files to extend the chiller delay timer and change the conductivity setting for the detection of RNA Wash2 liquid.
P100022/S016
10/26/15
135-Day
Zilver® PTX® Drug-Eluting Peripheral Stent
Cook Medical Incorporated
Bloomington, IN 47402
Approval for the addition of a stent reclaim process.
P100034/S013
10/5/15
Panel-Track
Optune™ (Formerly the NovoTTF-100A System)
Novocure, Ltd.
Haifa, Israel
Approval for the Optune (formerly the NovoTTF-100A System). This device is indicated as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy. Optune was previously approved in 2011 for the treatment of recurrent GBM with the following Indications for Use (IFU): Optune™ is indicated following histologically-or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
P100040/S021
10/30/15
180-Day
Valiant Thoracic Stent Graft with the Captivia Delivery System
Medtronic Vascular
Santa Rosa, CA 95403
Approval for an update to the Valiant Thoracic Stent Graft with Captivia Delivery System’s Instructions for Use (IFU) to include the VALOR II post approval study data.
P100041/S055
10/19/15
135-Day
Edwards SAPIEN Transcatheter Heart Valve
Edwards Lifesciences, LLC.
Irvine, CA
92614
Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier.
P110002/S010
10/6/15
180-Day
Mobi-C® Cervical Disc Prosthesis
LDR Spine USA, Incorporated
Austin, TX
78750
Approval for modifications to the Mobi-C labeling.
P110009/S010
10/6/15
180-Day
Mobi-C® Cervical Disc Prosthesis
LDR Spine USA, Incorporated
Austin, TX
78750
Approval for modifications to the Mobi-C labeling.
P110021/S042
10/19/15
135-Day
Edwards SAPIEN Transcatheter Heart Valve
Edwards Lifesciences, LLC.
Irvine, CA
92614
Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier.
P110033/S15
10/6/15
Real-Time
Juvéderm Voluma XC
Allergan
Irvine, CA
92623
Approval for an improvement to the method used to measure HA content of final JUVÉDERM and VOLUMA XC products during batch release.
P120004/S001
10/16/15
180-Day
Parascript® AccuDetect® 7.0
Parascript, LLC
Longmont, CO 80503
Approval for Parascript AccuDetect version 7.0.
P120010/S001
10/2/15
135-Day
MiniMed 530G System
Medtronic MiniMed
Northridge, CA 91325
Approval for adding duplicate existing manufacturing steps to the preparation of bulk glucose oxidase (GOx) performed by the supplier for use in the sponsor’s Enlite Sensor (Model: MMT-7008) and Sof-Sensor (Models: MMT-7002 and MMT-7003) Devices. The Enlite Sensor is a component of the MiniMed 530G System. The Sof-Sensor is a component of the Paradigm REAL-Time, Paradigm REALTime Revel, Guardian REAL-Time, MiniLink REAL-Time, IPro Recorder and IPro2 Professional Continuous Glucose Monitoring systems.
P120010/S046
10/2/15
Panel-Track
MiniMed 530G System with Threshold Suspend featuring SmartGuard™ Technology
Medtronic, Inc.
Northridge, CA 91325
Approval for the MiniMed 530G System with Threshold Suspend featuring SmartGuard technology. This device is indicated for the following: The MiniMed 530G System is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 530G System can be programmed to automatically suspend delivery of insulin when the sensor glucose value falls below a predefined threshold value. The MiniMed 530G System consists of the following devices that can be used in combination or individually: MiniMed 530G Insulin Pump, Enlite Sensor, Enlite Serter, the MiniLink Real-Time System, the Bayer Contour NextLink glucose meter, CareLink Professional Therapy Management Software for Diabetes, and CareLink Personal Therapy Management Software for Diabetes. The system requires a prescription. The MiniMed 530G System is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 530G System. The MiniMed 530G System is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm to take measures to prevent or treat hypoglycemia himself. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s Health Care Provider.
P120012/S009
10/9/15
Real-Time
RealTime HCV Genotype II
Abbott Molecular, Inc.
Des Plaines, IL 60018
Approval for two changes to the application specification files to extend the chiller delay timer and change the conductivity setting for the detection of RNA Wash2 liquid.
P120024/S001
10/21/15
Real-Time
activL® Artificial Disc
Aesculap Implant Systems, LLC
Center Valley, PA 18034
Approval for changes to the activL instrument trays.
P130006/S020
10/14/15
180-Day
GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Approval for a Post-Approval Study labeling update regarding revisions to the Instructions for Use to include the final study results for the RELINE Extended Follow-Up Study.
P130007/S003
10/30/15
135-Day
Animas Vibe System
Animas Corporation
West Chester, PA 19380
Approval for a change to the manufacturing location and process for spray paint coating of the Animas Vibe insulin pump outer plastic base and cover. The Animas Vibe insulin pump is a component of the Animas Vibe System.
P130007/S008
11/3/15
Real-Time
Animas® Vibe™ System
Animas Corporation
West Chester, PA 19380
Approval for replacing the flash memory of the Printed Circuit Board Assembly (PCBA) used in the Animas® VibeTM Insulin Pump, a component of the Animas® Vibe System, as well as subsequent software changes.
P130009/S004
10/19/15
135-Day
Edwards SAPIEN XT Transcatheter Heart Valve; Edwards
Qualcrimp Crimping Accessory
Edwards Lifesciences, LLC.
Irvine, CA
92614
Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier.
P130009/S034
10/9/15
Panel-Track
Edwards SAPIEN XT™ Transcatheter Heart Valve and Accessories, (NovaFlex+ Delivery System with Crimp Stopper and Qualcrimp Crimping Accessory Laminated or Cloth, Edwards Expandable Introducer sheath Set, Ascendra+ delivery system with crimp stopper,
Ascendra+ Introducer Sheath Set, and Edwards Crimper
Edwards Lifesciences LLC
Irvine, CA
92614
Approval for the SAPIEN XT Transcatheter Heart Valve, Model 9300TFX, and Accessories. This device is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).
P140018/S001
10/7/15
Real-Time
VenaSeal Closure System
Covidien
Plymouth, MN 55441
Approval for the use of a single sterile barrier packaging system for the VenaSeal Closure System, in place of the double sterile barrier system
30-Day Notices (135 Day Supplement was not required)
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
N18033/S079
10/15/15
VISTAKON (etafilconA) Brand Contact Lenses
Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Changes to the supplier of the mold material.
N970012/S112
10/30/15
AMS 700 Inflatable Penile Prosthesis
Boston Scientific, Inc.
Minnetonka, MN 55343
Changes in the fabric wash process water level range, the rinse cycle pH testing, and the inspection of cut fabric angle measurement.
P830061/S122
10/2/15
Capsure and Vitatron Lead Models
Medtronic, Inc.
Mounds View, MN 55112
Implementation of new serial number printing software within the existing traceability system.
P840001/S313
10/14/15
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimulation Leads
Medtronic, Inc.
Minneapolis, MN 55432
New laser welding equipment for the spinal cord stimulation (SCS) and deep brain stimulation (DBS systems).
P840001/S314
10/30/15
External Neurostimulator; Itrel 4 Programmable Neuro-stimulator for Spinal Cord Stimulation; RestorePrime Neurostimulator; PrimeAdvanced Neurostimulator; RestoreUltra Neurostimulator; RestoreAdvanced Neurostimulator; RestorSensor Neurostimulator; PrimeAdvanced SureScan MRI Neurostimulator; RestoreUltra SureScan MRI Rechargeable Neurostimulator; RestoreAdvanced SureScan MRI Rechargeable Neurostimulator; RestoreSensor SureScan MRI Rechargeable Neurostimulator
Medtronic Inc.
Minneapolis, MN 55432
Update the manufacturing execution system (MES) at Medtronic Tempe Campus (MTC) in Tempe, Arizona.
P850079/S068
10/15/15
Methafilcon A and B Soft (hydrophilic) Extended Wear Contact Lenses
CooperVision, Inc.
Pleasanton, CA 94588
Change in material (FINA) for the blister packaging and new supplier for this material.
P860004/S237
10/21/15
SynchroMed Infusion System
Medtronic Neuromodulation
Minneapolis, MN 55432
Addition of Medtronic Puerto Rico Operations Co. in Juncos, Puerto Rico.
P860004/S238
10/30/15
SynchroMed II Infusion System
Medtronic Inc.
Minneapolis, MN 55432
To update the manufacturing execution system (MES) at Medtronics hybrid supplier, Medtronic Tempe Campus (MTC) in Tempe, Arizona.
P860057/S139
10/27/15
Carpentier-Edwards PERIMOUNT Pericardial Aortic Mitral Bioprostheses
Edwards Lifesciences, LLC
Irvine, CA
92614
The addition of a terminal liquid sterilization oven.
P890003/S337
10/2/15
Vitatron Brilliant S+VDD Lead
Medtronic, Inc.
Mounds View, MN 55112
Implementation of new serial number printing software within the existing traceability system.
P890055/S061
10/8/15
Codman 3000 Constant-Flow Infusion Pump & MedStream Programmable Infusion System Accessories
Codman & Shurtleff, Inc.
Raynham, MA 02767
Changes to the sterilization process: 1) Steam injection rate currently at 20 mbar/min will change to 5 mbar/min; 2) Gas injection rate currently at 25 mbar/min will change to 20 mbar/min; 3) Minimum primary degassing time of 10 hours will change to 8 hours; 4) The handles from the sterilization shipper, number 197548018, will be removed; 5) Add a second Ethylene Oxide (EO) Sterilization Chamber (Chamber #4; 6) A minimum EO sterilization load in Chamber #3 (existing chamber) and Chamber #4; and 7) A 2X EO sterilization for both Chamber #3 and #4.
P900056/S151
10/13/15
Rotoblator Rotational Angioplasty System Guidewire
Boston Scientific Corporation
Maple Grove, MN 55311
The addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer.
P900061/S137
10/2/15
End Cap, Upsizing Sleeve
Medtronic, Inc.
Mounds View, MN 55112
Implementation of new serial number printing software within the existing traceability system.
P910023/S363
10/7/15
Current+ DR, Current+ VR, Ellipse DR, Ellipse VR, Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR
St. Jude Medical
Sylmar, CA
91342
Addition of an alternate feedthru supplier for high voltage capacitors utilized in the devices.
P920015/S162
10/2/15
Sprint Quattro Leads, Subcutaneous Lead, Transvene CS/SVC Lead
Medtronic, Inc.
Mounds View, MN 55112
Implementation of new serial number printing software within the existing traceability system.
P920015/S165
10/30/15
Sprint Quattro Lead
Medtronic, Inc.
Mounds View, MN 55112
Manufacturing transfer to a different internal supplier for the Dexamethasone Acetate (DXAC) Monolithic Controlled Release Device (MCRD) component used in the device.
P920047/S085
10/1/15
Blazer II, Blazer II HTD, Blazer Prime HTD
Boston Scientific Corporation
San Jose, CA
95134
Increased capacity shipping cartons and an increased pallet configuration.
P920047/S086
10/13/15
Blazer II Cardiac Ablation Catheter and Cable
Boston Scientific Corporation
Maple Grove, MN 55311
Addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer.
P930039/S137
10/2/15
SureFix Lead
Medtronic, Inc.
Mounds View, MN 55112
Implementation of new serial number printing software within the existing traceability system.
P930039/S139
10/7/15
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
Medtronic, Inc.
Mounds View, MN 55112
Welding process change, from a manual welding process to a semi-automated welding process for the Hedix Subassembly of the lead systems.
P930039/S141
10/30/15
CapSureFix Lead
Medtronic, Inc.
Mounds View, MN 55112
Manufacturing transfer to a different internal supplier for the Dexamethasone Acetate (DXAC) Monolithic Controlled Release Device (MCRD) component used in the device.
P950024/S065
10/2/15
CapSure Epicardial Pacing Leads
Medtronic, Inc.
Mounds View, MN 55112
Implementation of new serial number printing software within the existing traceability system.
P960004/S074
10/13/15
FINELINE II STEROX Lead Endocardial Suture Sleeve Accessory
Boston Scientific Corporation
St. Paul, MN
55112
Insourcing Boston Scientific Corporation as a manufacturer for the molded silicone slit suture sleeve accessory.
P960009/S238
10/14/15
Activa Deep Brain Stimulation Therapy System
Medtronic, Inc.
Minneapolis, MN 55432
New laser welding equipment for the spinal cord stimulation (SCS) and deep brain stimulation (DBS systems).
P960009/S239
10/30/15
External Neurostimulator; Activa PC Neurostimulator; Activa SC Neurostimulator; Activa RC Neurostimulator
Medtronic Inc.
Minneapolis, MN 55432
Update the manufacturing execution system (MES) at Medtronic Tempe Campus (MTC) in Tempe, Arizona.
P960016/S057
10/21/15
Livewire TC Steerable Electrophysiology Catheter, Safire Bi-directional Ablation Catheter`
St. Jude Medical
St. Paul, MN
55147
Remove a redundant run-in test for the Ampere system from the manufacturing process.
P960022/S011
10/19/15
Bausch & Lomb Soflens Toric (alphafilcon A) Contact Lens
Bausch & Lomb, Inc.
Rochester, NY 14609
Qualifying an alternate supplier of a critical raw material component for the Bausch & Lomb Soflens Toric (alphafilcon A) contact lens.
P960040/S355
10/7/15
Incepta ICD, Energen ICD, Punctua ICD, Dynagen ICD, Inogen ICD, Origen ICD,
Boston Scientific Corporation
St. Paul, MN
55112
Manufacture the spring connector block housing components for the referenced pulse generators at Boston Scientific Corporation facility, St. Paul, Minnesota.
P960040/S356
10/19/15
ORIGEN EL ICD, ORIGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD,
Boston Scientific Corporation
St. Paul, MN
55112
Convert one Super Output Module (SOM) to another SOM by subjecting it to a temperature cycle screening process.
P960040/S357
10/21/15
PUNCTUA, ENERGEN, INCEPTA, ORIGEN INOGEN, DYNAGEN
Boston Scientific Corporation
St. Paul, MN
55112
Eliminate an equipment check performed on equipment used to test parylene coating thickness of batteries and capacitors used in the devices.
P970004/S205
10/30/15
InterStim II Neurostimulator
Medtronic Inc.
Minneapolis, MN 55432
Update the manufacturing execution system (MES) at Medtronics hybrid supplier, Medtronic Tempe Campus (MTC), Tempe, Arizona.
P970021/S043
10/2/15
GYNECARE THERMACHOICE III Uterine Balloon Therapy System
Ethicon, Inc.
Somerville, NJ 08876
Changes to the manufacturing process, Process Specification For Drive Assembly, Thermachoice Catheters 3.0, for the GYNECARE THERMACHOICE Balloon Catheter.
P970051/S134
10/14/15
Nucleus CI512 and CI522 Cochlear Implant
Cochlear Americas
Centennial, CO 80111
Addition of rework and inspection steps to manufacturing procedures at the Macquarie manufacturing facility.
P980003/S064
10/13/15
Chilli II Cooled Ablation Catheter and Cable
Boston Scientific Corporation
Maple Grove, MN 55311
Addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer.
P980016/S549
10/14/15
Evera MRI XT DR SureScan ICD, Evera MRI XT VR SureScan ICD, Evera MRI S DR SureScan ICD, Evera MRI S VR SureScan ICD
Medtronic, Inc.
Mounds View, MN 55112
Manufacturing changes: Expansion of a controlled environment area, Addition of a laser welding system, Update to hybrid tracking during manufacturing, Connector molding manufacturing process change, Addition of a soak oven temperature verification, and Implementation of a continuous monitoring system.
P980016/S552
10/23/15
Evera MRI ICD; Evera DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Maximo II ICD; Maximo II ICD; Protecta ICD; Protecta XT ICD; Secura ICD; Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging.
P980016/S553
10/22/15
Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Maximo II ICD; Protecta ICD; Protecta XT ICD; Secura ICD; Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes.
P980016/S554
10/29/15
Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD
Metronic, Inc.
Mounds View, MN 55112
Change to the high voltage capacitor weld monitoring frequency.
P980035/S440
10/23/15
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG
Medtronic, Inc.
Mounds View, MN 55112
Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging.
P980035/S441
10/22/15
Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Relia IPG
Medtronic, Inc.
Mounds View, MN 55112
Update the manufacturing execution system (MES) to ACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes.
P980037/S049
10/30/15
AngioJet Thrombectomy System
Boston Scientific Corporation
Minneapolis, MN 55433
Change in the bioburden assessment.
P000012/S054
10/15/15
COBAS AMPLICOR Hepatitis C Virus Test version 2.0 and COBAS AmpliPrep/COBAS AMPLICOR HCV Test version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Elimination of an in-process functional test for a final component.
P000037/S043
10/5/15
On-X Prosthetic Heart Valve
On-X Life Technologies, Inc.
Austin, TX
78752
The addition of a Coordinate Measuring Machine.
P010012/S400
10/7/15
Incepta ICD Energen ICD, Punctua ICD, Dynagen ICD, Inogen ICD, Origen ICD
Boston Scientific Corporation
St. Paul, MN
55112
Manufacture the spring connector block housing components for the referenced pulse generators at Boston Scientific Corporation facility in St. Paul, Minnesota.
P010012/S401
10/19/15
ORIGEN CRT-D, ORIGEN X4 CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D
Boston Scientific Corporation
St. Paul, MN
55112
Convert one Super Output Module (SOM) to another SOM by subjecting it to a temperature cycle screening process.
P010012/S402
10/21/15
PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN,
DYNAGEN
Boston Scientific Corporation
St. Paul, MN
55112
Eliminate an equipment check performed on equipment used to test parylene coating thickness of batteries and capacitors used in the device models.
P010015/S280
10/2/15
Attain Bipolar OTW Lead, Attain OTW LV Lead
Medtronic, Inc.
Mounds View, MN 55112
Implementation of new serial number printing software within the existing traceability system.
P010015/S282
10/22/15
Consulta CRT-P; Syncra CRT-P; Viva CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes.
P010019/S041
10/13/15
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended Wear (NIGHT & DAY, AIR OPTIX NIGHT & DAY AQUA, O2OPTIX, AIR OPTIX AQUA, AIR OPTIX for ASTIGMATISM, AIR OPTIX AQUA MULTIFOCAL)
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Introduce an alternate source of isopropyl alcohol.
P010030/S066
10/2/15
LifeVest Wearable Defibrillator-Model WCD 4000
ZOLL Manufacturing Corporation
Pittsburgh, PA 15238
Alternate supplier, Sun Star, Inc., in Latrobe, Pennsylvania for the ECG backcover with retainer dual and ECG back cover with retainer single.
P010031/S514
10/22/15
Brava CRT-D; Brava Quad CRT-D; Concerto II CRT-D; Consulta CRT-D; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes.
P010031/S515
10/23/15
Brava CRT-D; Concerto II CRT-D; Consulta CRT-D; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging.
P010031/S516
10/29/15
Brava CRT-D; Brava Quad CRT-D; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Change to the high voltage capacitor weld monitoring frequency.
P010032/S101
10/15/15
Tripole, Tripole 16c, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitrode winged, Lamitrode, Penta, Quattrode, Octrode, Dual 4 Extension, Single 8 Extension, A127 Extension, 8 Channel Adapters, Compustim Adapter
St. Jude Medical Neuromodulation
Plano, TX
75024
Implementation of a change to the tumbling process of electrodes used on the SCS leads, extensions, and adapters.
P020025/S079
10/1/2015
Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP
Boston Scientific Corp.
San Jose, CA
95134
Increased capacity shipping cartons and an increased pallet configuration.
P020025/S080
10/13/15
Blazer II XP Cardiac Ablation Catheter and Cable
Boston Scientific Corporation
Maple Grove, MN 55311
Addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer.
P020047/S063
10/22/15
Multi-Link Vision, Multi-Link Mini-Vision, and Multi-Link 8 Coronary Stent Systems
Abbott Vascular
Temecula, CA 92591
Change to the stent process monitoring system.
P030011/S035
10/29/15
SynCardia temporary Total Artificial Heart (TAH-t) System
SynCardia Systems, Inc.
Tucson, AZ
85713
Alternate assembler for certain Freedom Driver printed circuit board assemblies.
P030017/S236
10/9/15
Precision Spectra Spinal Cord Stimulator (SCS) System
Boston Scientific Corp.
Valencia, CA
91355
Process change to the welding process for attaching the battery to the Kovar tabs on the printed circuit board assembly (PCBA) during the manufacture of Implantable Pulse Generator (IPG) devices.
P030017/S237
10/22/15
Precision Spectra Cord Stimulator (SCS) System
Boston Scientific Corporation
Valencia, CA
91355
Implementation of an update to the test equipment system and associated software used for testing Continuity and HiPot on the Artisan (2X8) Surgical (Paddle) Lead and CoverEdge 32 Contact Surgical (Paddle) Leads.
P030054/S293
10/7/15
Promote+, Quadra Assura Unify, Unify Assura, Unify Quadra
St. Jude Medical
Sylmar, CA
91342
Addition of an alternate feedthru supplier for high voltage capacitors utilized in the devices.
P040014/S027
10/21/15
Therapy Ablation Catheters
St. Jude Medical
St. Paul, MN
55147
Remove a redundant run-in test for the Ampere system from the manufacturing process.
P040042/S032
10/21/15
Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters
St. Jude Medical
St. Paul, MN
55147
Remove a redundant run-in test for the Ampere system from the manufacturing process.
P040047/042
10/1/15
COAPTITE Injectable Implant for the treatment of Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency in Adult Females
Merz North America
Franksville, WI 53126
Lifting the requirement that manufacturing equipment remain dedicated to specific products.
P050037/S062
10/1/15
RADIESSE Injectable Implant
Merz North America
Franksville, WI 53126
Lifting the requirement that manufacturing equipment remain dedicated to specific products.
P050047/S051
10/23/15
Juvederm Hyaluronate Gel Implants
Allergan
Irvine, CA
92612
Implementation of an automated visual inspection process and accompanying in-process control for inspecting the 0.8 mL syringe configuration of Juvederm Hyaluronate Gel Implants.
P050052/S072
10/1/15
RADIESSE Injectable Implant
Merz North America
Franksville, WI 53126
Lifting the requirement that manufacturing equipment remain dedicated to specific products.
P060019/S034
10/21/15
Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters
St. Jude Medical
St. Paul, MN
55147
Remove a redundant run-in test for the Ampere system from the manufacturing process.
P060037/S040
10/2715
Zimmer Nexgen LPS-Flex Mobile and LPS Mobile Bearing Knee System
Zimmer, Incorporated
Warsaw, IN
46581
Add a new contract laboratory to increase biological indicator verification testing capacity for the LPS mobile tibial articular surface components.
P060040/S044
10/14/15
Thoratec Heartmate II Left Ventricular Assist System (lvas)
Thoratec Corporation
Pleasanton, CA 94588
Addition of an alternate supplier for a critical component in the HeartMate II LVAS Pocket Controller.
P070015/S131
10/22/15
XIENCE V and nano Everolimus Eluting Coronary Stent Systems
Abbott Vascular Inc.
Temecula, CA 92589
Change to the stent process monitoring system.
P070027/S045
10/15/15
Talent Occluder with Occluder Delivery System
Medtronic Vascular, Inc.
Santa Rosa, CA 95403
Implementation of a new Internal Process Challenge Device (IPCD) inoculation method for biannual sterilization requalification.
P070027/S046
10/23/15
Talent Occluder with Occluder Delivery System
Medtronic Vascular, Inc.
Santa Rosa, CA 95403
Change in the inoculation process site for sterilization re