Summary of PMA Originals & Supplements
Approved Originals: 3
Supplements: 74
Summary of PMA Originals Under Review
Total Under Review: 53
Total Active: 26
Total On Hold: 27
Summary of PMA Supplements Under Review
Total Under Review: 565
Total Active: 401
Total On Hold: 164
Summary of All PMA Submissions Received
Originals: 4
Supplements: 83
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 74
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 168.6
FDA Time: 113.5 Days MFR Time: 55.1 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P120020 3/28/14 |
SUPERA® Peripheral Stent System | Abbott Vascular Santa Clara, CA 95054 |
Approval for the SUPERA® Peripheral Stent System. This device is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 4.0 to 6.5 mm, and lesion lengths up to 140 mm. |
P130015 3/14/14 |
Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg | Roche Diagnostics Indianapolis, IN 46250 |
Approval for the Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg. This device is indicated for: Elecsys HBeAg Immunoassay The Elecsys HBeAg immunoassay is intended for the in vitro qualitative determination of hepatitis B e antigen (HBeAg) in human serum or plasma (K2-EDTA, lithium or sodium heparin, and sodium citrate) in adult patients with symptoms of hepatitis or at risk for hepatitis B virus (HBV) infection. The assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B or recovery from hepatitis B infection. The electrochemilumin-escence immunoassay ECLIA is intended for use on the MODULAR ANALYTICS E170 analyzer. Elecsys PreciControl HBeAg Elecsys PreciControl HBeAg is used for quality control of the Elecsys HBeAg immunoassay on the MODULAR ANALYTICS E170 analyzer. |
P130016 3/20/14 |
Nucleus® Hybrid™ L24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for the Nucleus® Hybrid™ L24 Cochlear Implant System. The Nucleus® Hybrid™ L24 Cochlear Implant System is intended to provide electric stimulation to the mid-to-high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity. The system is indicated for unilateral use in patients aged 18 years and older who have residual low-frequency hearing sensitivity and severe to profound high frequency sensorineural hearing loss, and who obtain limited benefit from appropriately fit bilateral hearing aids. Typical preoperative hearing of candidates ranges from normal to moderate hearing loss in the low frequencies (thresholds no poorer than 60 dB HL up to and including 500 Hz), with severe to profound mid to high frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted, and moderately severe to profound mid to high frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥ 60 dB HL) in the contralateral ear. The CNC word recognition score will be between 10% and 60%, inclusively, in the ear to be implanted in the preoperative aided condition and in the contralateral ear will be equal to or better than that of the ear to be implanted but not more than 80% correct. Prospective candidates should go through a suitable hearing aid trial, unless already appropriately fit with hearing aids. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
N970012/S097 3/6/14 135-Day |
AMS 700 Implantable Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for changes to manual inspection methods, addition of an alternate automated inspection method and redefinition of the diameter measurement region. |
P810006/S048 3/18/14 135-Day |
COLLASTAT Absorbable Collagen Hemostatic Agents | Integra Lifesciences Plainsboro, NJ 85360 |
Approval for adding increased system capacity for water purification of the current Reverse Osmosis/Electro-Deionization Water Purification System (ROEDI). |
P830060/S078 3/31/14 Real-Time |
VENTAK P Automataic Implantable Cardioverter Defibrillator System/ Lead TUNNELER Kit | Boston Scientific Corporation St. Paul, MN 55112 |
Approval to add sterilization detail information and to remove the CIDEX cleaning step from the Instructions for Use. |
P840001/S261 3/13/14 Special |
Medtronic Spinal Cord Stimulation Systems |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for “Changes Being Effected to the Labeling of Medtronic Spinal Cord Stimulation Systems.” Specifically, a possible adverse event – delayed spinal cord compression due to epidural mass formation – is being added to the labeling. |
P840062/S035 3/18/14 135-Day |
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressing | Integra Lifesciences Plainsboro, NJ 85360 |
Approval for adding increased system capacity for water purification of the current Reverse Osmosis/Electro-Deionization Water Purification System (ROEDI). |
P850010/S046 3/18/14 135-Day |
HELIOSTAT and Helitene Absorbable Hemostatic Agents, Collagen Based | Integra Lifesciences Plainsboro, NJ 85360 |
Approval for adding increased system capacity for water purification of the current Reverse Osmosis/Electro-Deionization Water Purification System (ROEDI). |
P880006/S085 3/20/14 180-Day |
Sensolog/Dialog/ Regency Family of Pacemakers |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for additional Assurity+, Assurity, and Endurity Pacemakers, the Allure and Allure Quadra Cardiac Resynchronization Therapy Pacemakers (CRT-P), Model 3330 Version 17.1.1 Software, and Merlin Pacing System Analyzer (PSA) Model EX3100. |
P880086/S230 3/20/14 180-Day |
Affinity/Integrity/ Victory/Zephyr/ Accent Family of Pacemakers |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for additional Assurity+, Assurity, and Endurity Pacemakers, the Allure and Allure Quadra Cardiac Resynchronization Therapy Pacemakers (CRT-P), Model 3330 Version 17.1.1 Software, and Merlin Pacing System Analyzer (PSA) Model EX3100. |
P880086/S238 3/31/14 Real-Time |
Identity, SustainXL, Verify, Victory, Zephyr, and Accent Families of Pacemaker Devices | St. Jude Medical Sylmar, CA 91342 |
Approval for a modification in the separator component utilized in the batteries of the implantable pulse generators. |
P900033/S032 3/18/14 135-Day |
INTEGRA Artificial Skin Dermal Regeneration Template | Integra Lifesciences Plainsboro, NJ 85360 |
Approval for adding increased system capacity for water purification of the current Reverse Osmosis/Electro-Deionization Water Purification System (ROEDI). |
P910023/S311 3/20/14 180-Day |
Ellipse/Fortify Assura Family of Implantable Cardioverter Defibrillators | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for additional Assurity+, Assurity, and Endurity Pacemakers, the Allure and Allure Quadra Cardiac Resynchronization Therapy Pacemakers (CRT-P), Model 3330 Version 17.1.1 Software, and Merlin Pacing System Analyzer (PSA) Model EX3100. |
P910023/S328 3/31/14 Real-Time |
Current, Fortify, and Fortify Assura Families of ICD Devices | St. Jude Medical Sylmar, CA 91342 |
Approval for a modification in the separator component utilized in the batteries of the implantable pulse generators. |
P910077/S138 3/20/14 180-Day |
LATTITUDE Consult System- LATITUDE Consult Communicator; LATITUDE Consult System Software |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the LATITUDE Consult System which includes the Communicator Model 6299 and Application Software Server Model 6294. |
P940010/S011 3/21/14 Real-Time |
Optiguide Fiber Optic Diffuser (DCYL Cyclindrical Diffuser Series | Pinnacle Biologics Bannockburn, IL 60015 |
Approval for: 1) A change in the material of the tubing cap placed over the diffuser tip from a polycarbonate material to an ETFE tubing material; 2) The use of heat bonding for the ETFE tubing material in place of the adhesive bonding presently used for the tubing cap; 3) Elimination of the orange sheath presently added over the inactive length of the presently marketed fiber optic diffusers; and 4) Modification of the diffuser tip, specifically: a) use of a silver mirror to replace the dielectric material presently used; b) the use of a silicon diffuser mix between the end of the fiber core and dielectric mirror; and c) the addition of diffuser shrink tubing to the distal end. The device, as modified, will be marketed under the trade name Optiguide Fiber Optic Diffuser DCYL 700 Series and is indicated for use in Photodynamic Therapy with PHOTOFRIN (porfimer sodium) for injection for: 1) Palliation of patients with completely obstructing esophageal cancer or patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy; 2) Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC); 3) Treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated; and 4) Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) among patients who are not candidates for esophagectomy. |
P950029/S086 3/18/14 Real-Time |
REPLY/ESPIRIT PACEMAKERS | Sorin CRM USA Arvada, CO 80004 |
Approval for updated Orchestra/Orchestra Plus Programmer software, Reply 1.16 and Paceart 1.12. |
P950032/S070 3/10/14 135-Day |
Apligraf | Organogenesis, Incorporated Canton, MA 02021 |
Approval of an alternate source of a critical material used in the manufacture of Apligraf. |
P960016/S043 3/12/14 135-Day |
Livewire TCTM Cardiac Ablation System | St. Jude Medical St. Paul, MN 55117 |
Approval to semi-automate the process to decore the mandrel from the catheter shaft subassembly. |
P960016/S044 3/21/14 180-Day |
Livewire TCTM Cardiac Ablation System -Electrophysiology Catheter and Safire Bi-directional Ablation Catheter | St. Jude Medical St. Paul, MN 55117 |
Approval for modification to the currently marketed 1500T9 series cardiac ablation generator. The device, as modified, will be marketed under the trade name Ampere Generator and is indicated for: The Ampere Generator is intended for use with compatible ablation catheters in creating endocardial lesions during cardiac ablation procedures to treat cardiac arrhythmias. |
P970013/S055 3/20/14 180-Day |
Microny Family of Pacemakers | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for additional Assurity+, Assurity, and Endurity Pacemakers, the Allure and Allure Quadra Cardiac Resynchronization Therapy Pacemakers (CRT-P), Model 3330 Version 17.1.1 Software, and Merlin Pacing System Analyzer (PSA) Model EX3100. |
P970021/S040 3/17/14 Real-Time |
GYNECARE THERMACHOICE Uterine Balloon Therapy (UBT) System | ETHICON, Inc. Somerville, NJ 08876 |
Approval for a change to the Heater Wire Shrink Tubing within the balloon. |
P970051/S113 3/5/14 135-Day |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for an alternate supplier of a manufacturing part. |
P980016/S455 3/5/14 Real-Time |
Evera S DR, Evera S VR, Evera XT DR, Evera XT VR Implantable Cardioverter-Defibrillators (ICDs) |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for design changes to the die stack used in the ICDs and CRT-Ds. |
P980016/S463 3/20/14 Real-Time |
Evera S, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a minor material change for the capacitor electrical Feedthrough. |
P980022/S150 3/13/14 Real-Time |
Paradigm REAL-Time Insulin Pump; Paradigm REAL-Time Revel Insulin Pump | Medtronic Minimed Northridge, CA 91325 |
Approval for changes to the stack assemblies and battery tube assembly to comply with RoHS (Restriction of Hazardous Substances) requirements. These changes include changes to five components on the stack assembly, a change in material for the bare printed circuit boards (PCBs) of the stack assembly and battery tube assembly, and a change to the solder material (from Tin/Lead to Tin/Silver/Copper) used on the PCBs. |
P980049/S085 3/6/14 180-Day |
Orchestra and Orchestra Plus Programmer; and Smartview Remote Monitoring & Smartview Monitor PSTN & GPRS |
Sorin CRM USA, Inc. Arvada, CO 80004 |
Approval for: 1) A firmware patch for the implantable device with the microprocessor (uP) V4B; 2) A new firmware version for the uP V4C and V4D; 3) The hardware modifications for the implantable devices; 4) The updates/ modifications for the programmer application software; and 5) The updates/ modifications for the Remote Monitoring System (RMS). |
P980049/S090 3/18/14 Real-Time |
PARADYM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | Sorin CRM USA Arvada, CO 80004 |
Approval for updated Orchestra/Orchestra Plus Programmer software, Reply 1.16 and Paceart 1.12. |
P990012/S020 3/21/14 Real-Time |
Elecsys HBsAg Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for the software change from version 06-07 to 06-08 on the Elecsys 2010 analyzer to correct the possibility of incorrect results after automatic dilution. |
P990056/S020 3/21/14 Real-Time |
Elecsys Total PSA Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for the software change from version 06-07 to 06-08 on the Elecsys 2010 analyzer to correct the possibility of incorrect results after automatic dilution. |
P990074/S028 3/27/14 Real-Time |
Natrelle Saline-Filled Breast Implants | Allergan Goleta, CA 93117 |
Approval for a change to the material used for the fill tube tip and luer adapter of the fill tube assembly for Natrelle Saline-Filled Breast Implants from Pro-fax PD626 polypropylene homopolymer to P5M6K-080 polypropylene copolymer. |
P000027/S018 3/21/14 Real-Time |
Elecsys Free PSA Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for the software change from version 06-07 to 06-08 on the Elecsys 2010 analyzer to correct the possibility of incorrect results after automatic dilution. |
P000057/S007 3/6/14 Real-Time |
Ascension® MCP | Ascension Orthopedics, Incorporated Austin, TX 78754 |
Approval for a change in packaging. |
P010031/S417 3/5/14 Real-Time |
Brava, Viva S, Viva XT Cardiac Resynchronization Therapy- Defibrillators (CRT-Ds) |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for design changes to the die stack used in the ICDs and CRT-Ds. |
P010031/S425 3/20/14 Real-Time |
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a minor material change for the capacitor electrical feedthrough. |
P010032/S074 3/21/14 Real-Time |
Protégé System | St. Jude Medical Plano, TX 75024 |
Approval for labeling modifications to change the name of the Eon Mini IPG to Protégé (Model 3789); labeling modifications to change the name of the Eon Mini LE Charge to Prodigy Charger (Model 3730); and minor software modifications to the Patient Programmer and Rapid Programmer (Model 3852) to recognize the device with the new Protégé device name and model number. |
P010054/S022 3/21/14 Real-Time |
Elecsys anti-HBs Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for the software change from version 06-07 to 06-08 on the Elecsys 2010 analyzer to correct the possibility of incorrect results after automatic dilution. |
P020045/S046 /S046 3/6/14 180-Day |
7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System |
Medtronic CryoCath LP Pointe-Claire, Quebec, Canada H9R 5Z8 |
Approval for a manufacturing site located at Plexus Corporation, in Buffalo Grove, Illinois. |
P030009/S074 3/4/14 Special |
Integrity Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a reconciliation process for compliance chart labels. |
P030011/S023 3/18/14 Real-Time |
SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System |
SynCardia Systems, Inc. Tucson, AZ 85713 |
Approval for a minor change to the Companion 2 Driver System External Battery. |
P030017/S185 3/7/14 Real-Time |
Precision SpectraTM Spinal Cord Stimulator (SCS) System – Addition of the Precision Spectra Observational Mechanical Gateway (OMG) | Boston Scientific Neuromodulation Valencia, CA 91355 |
Approval for the Precision Spectra Observational Mechanical Gateway (OMG) to be used as an adjunct accessory with the Precision Spectra Spinal Cord Stimulator (SCS) System. |
P030035/S108 3/20/14 180-Day |
Frontier/Frontier II/Anthem Family of Cardiac Resynchronization Therapy Pacemakers | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for additional Assurity+, Assurity, and Endurity Pacemakers, the Allure and Allure Quadra Cardiac Resynchronization Therapy Pacemakers (CRT-P), Model 3330 Version 17.1.1 Software, and Merlin Pacing System Analyzer (PSA) Model EX3100. |
P030035/S116 3/31/14 Real-Time |
Anthem Family of CRT-P Devices | St. Jude Medical Sylmar, CA 91342 |
Approval for a modification in the separator component utilized in the batteries of the implantable pulse generators. |
P030053/S016 3/18/14 Real-Time |
Mentor MemoryGel® Silicone Gel-Filled Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Approval for the addition of thirty-one styles including sixteen Smooth Round Ultra High Profile devices: 350-5135BC, 350-5160BC, 350-5180BC, 350-5215BC, 350-5240BC, 350-5270BC, 350-5295BC, 350-5320BC, 350-5350BC, 350-5375BC, 350-5400BC, 350-5430BC, 350-5455BC, 350-5480BC, 350-5535BC, and 350-5590BC; and fifteen SILTEX® Round Ultra High Profile devices: 354-5135, 354-5160, 354-5185, 354-5215, 354-5240, 354-5270, 354-5295, 354-5320, 354-5350, 354-5375, 354-5400, 354-5430, 354-5455, 354-5480, and 354-5535. |
P030054/S241 3/20/14 180-Day |
Quadra Assura/Unify Assura Family of Cardiac Resynchronization Therapy Defibrillators |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for additional Assurity+, Assurity, and Endurity Pacemakers, the Allure and Allure Quadra Cardiac Resynchronization Therapy Pacemakers (CRT-P), Model 3330 Version 17.1.1 Software, and Merlin Pacing System Analyzer (PSA) Model EX3100. |
P030054/S259 3/31/14 Real-Time |
Promote, Quadra Assura, Unify, Unify Assura, and Unify Quadra Families of CDT-D Devices | St. Jude Medical Sylmar, CA 91342 |
Approval for a modification in the separator component utilized in the batteries of the implantable pulse generators. |
P040014/S021 3/21/14 180-Day |
IBI THERAPY CARDIAC ABLATION SYSTEM | St. Jude Medical St. Paul, MN 55117 |
Approval for modification to the currently marketed 1500T9 series cardiac ablation generator. The device, as modified, will be marketed under the trade name Ampere Generator and is indicated for: The Ampere Generator is intended for use with compatible ablation catheters in creating endocardial lesions during cardiac ablation procedures to treat cardiac arrhythmias. |
P040033/S023 3/16/14 Real-Time |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew, Incorporated Cordova, TN 38016 |
Approval for a packaging change for the BHR Femoral Heads and Acetabular Cups. |
P040037/S061 3/10/14 Real-Time |
GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface | W.L. Gore & Associates Flagstaff, AZ 86005 |
Approval for revised specification limits for manufacturing aids. |
P040042/S026 3/21/14 180-Day |
Therapy Dual 8, Therapy 8mm Thermistor, and Safire TX Ablation Catheters, and 1500T6 and 1500T9 RF Generator | St. Jude Medical St. Paul, MN 55117 |
Approval for modification to the currently marketed 1500T9 series cardiac ablation generator. The device, as modified, will be marketed under the trade name Ampere Generator and is indicated for: The Ampere Generator is intended for use with compatible ablation catheters in creating endocardial lesions during cardiac ablation procedures to treat cardiac arrhythmias. |
P040044/S049 3/28/14 135-Day |
Mynx Vascular Closure Device Product Family | Access Closure, Inc. Santa Clara, CA 95054 |
Approval for changes to the hydrogel conditioning cycle recipe. |
P050012/S052 3/5/14 Special |
Dexcom SEVEN® PLUS Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Approval for the following changes to the Dexcom Studio Software: support was added for Windows 8, Open Office, and Canadian English and Canadian French installations; improved system performance for large clinics that manage large numbers of patients; the word “Blinded” was added to every chart when the receiver data is downloaded in “Blinded” mode; the tooltip was translated into various languages; and labeling changes were made to the Dexcom Studio™ Software guide, G4™ Sensor manual, and receiver replacement guide. |
P050023/S075 3/11/14 Real-Time |
Ilesto, Iforia, and Lumax Family of ICD Devices; Ilesto and Lumax Family of CRT-D Devices |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for a modification to coupling capacitors in the electronic modules used in the devices. |
P050037/S042 3/7/14 135-Day |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Approval for the qualification of an autoclave. |
P050037/S045 3/7/14 135-Day |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Approval for the qualification of an autoclave. |
P060019/S026 3/21/14 180-Day |
Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters, and 1500T9-CP RF Generators |
St. Jude Medical St. Paul, MN 55117 |
Approval for modification to the currently marketed 1500T9 series cardiac ablation generator. The device, as modified, will be marketed under the trade name Ampere Generator and is indicated for: The Ampere Generator is intended for use with compatible ablation catheters in creating endocardial lesions during cardiac ablation procedures to treat cardiac arrhythmias. |
P060027/S053 3/6/14 180-Day |
Paradym RF: VR, DR CRT-D; Paradym: VR, DR CRT-D |
Sorin CRM USA, Inc. Arvada, CO 80004 |
Approval for: 1) A firmware patch for the implantable device with the microprocessor (uP) V4B; 2) A new firmware version for the uP V4C and V4D; 3) The hardware modifications for the implantable devices; 4) The updates/ modifications for the programmer application software; and 5) The updates/ modifications for the Remote Monitoring System (RMS). |
P060033/S088 3/4/14 Special |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a reconciliation process for compliance chart labels. |
P060040/S030 3/28/14 180-Day |
Thoratec HeartMate II® LVAS | Thoratec Corporation Pleasanton, CA 94588 |
Approval for the addition of a Mobile Power Unit (MPU) for the HeartMate II® LVAS system. |
P080014/S019 3/4/14 180-Day |
CERVISTA HPV HR TEST | Gen-Probe Incorporated San Diego, CA 92121 |
Approval for a manufacturing site located at Gen-Probe Incorporated, San Diego, California for the manufacturing of the Cervista® HPV HR and the Cervista® HPV 16/18. |
P080015/S010 3/4/14 180-Day |
CERVISTA HPV HR TEST | Gen-Probe Incorporated San Diego, CA 92121 |
Approval for a manufacturing site located at Gen-Probe Incorporated, San Diego, California for the manufacturing of the Cervista® HPV HR and the Cervista® HPV 16/18. |
P100010/S031 3/19/14 135-Day |
ARCTIC FRONT AND ARCTIC FRONT ADVANCE CRYOABLATION CATHETERS | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a change in the equipment used to perform in process testing of the pressure sensor integrated in the blood detector board, the leak detector wire, and the thermocouples and removal of a redundant upstream testing of the pressure sensor function. |
P100012/S005 3/7/14 Real-Time |
PCM® Cervical Disc System | NuVasive Incorporated San Diego, CA 92121 |
Approval for design changes to the PCM Inserter and redefining and tightening implant tolerances. |
P100028/S003 3/28/14 180-Day |
Formula™ 535 Balloon-Expandable Renal Stent System | Cook Incorporated Bloomington, IN 47402 |
Approval for an additional delivery system (Formula 535 delivery system) for the Formula Balloon-Expandable Renal Stent System. |
P100032/S009 3/21/14 Real-Time |
Elecsys anti-HBc Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for the software change from version 06-07 to 06-08 on the Elecsys 2010 analyzer to correct the possibility of incorrect results after automatic dilution. |
P100041/S041 3/28/14 135-Day |
Edwards SAPIEN™ Transcatheter Heart Valve and Transfemoral Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for three changes pertaining to the cutting, tolerances, and measurement of the cloth skirt on the Edwards SAPIEN™ THV. |
P100047/S032 3/26/14 Real-Time |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Approval for a change of the thread locking adhesive used on the retention nut which secures the connector to the controller housing. |
P110013/S034 3/4/14 Special |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a reconciliation process for compliance chart labels. |
P110016/S010 3/21/14 180-Day |
THERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION | St. Jude Medical St. Paul, MN 55117 |
Approval for modification to the currently marketed 1500T9 series cardiac ablation generator. The device, as modified, will be marketed under the trade name Ampere Generator and is indicated for: The Ampere Generator is intended for use with compatible ablation catheters in creating endocardial lesions during cardiac ablation procedures to treat cardiac arrhythmias. |
P110019/S061 3/26/14 Real-Time |
XIENCE Xpedition Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval for a labeling change for the XIENCE Xpedition, XIENCE Xpedition SV, and the XIENCE Xpedition LL Everolimus Eluting Coronary Stent System for the OTW platform. This labeling change requested a shelf life extension from 24 to 36 months. |
P110020/S010 3/12/14 Real-Time |
cobas® 4800 BRAF V600 Mutation Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for changes to the cobas® 4800 SR2 System software architecture and Assay Specific Analysis Package (ASAP) software for the cobas® BRAF V600 Mutation Test and cobas® EGFR Mutation Test. |
P110021/S028 3/28/14 135-Day |
Edwards SAPIEN™ Transcatheter Heart Valveand Transfemoral and Transapical Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for three changes pertaining to the cutting, tolerances, and measurement of the cloth skirt on the Edwards SAPIEN™ THV. |
P120005/S014 3/5/14 Real-Time |
Dexcom G4™ PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Approval for the following changes to the Dexcom Studio™ Software: support was added for Windows 8, Open Office, and Canadian English and Canadian French installations; improved system performance for large clinics that manage large numbers of patients; the word “Blinded” was added to every chart when the receiver data is downloaded in “Blinded” mode; the tooltip was translated into various languages; and labeling changes were made to the Dexcom Studio™ Software guide, G4™ Sensor manual, and receiver replacement guide. |
P120006/S005 3/26/14 135-Day |
Ovation™ and Ovation Prime™ Abdominal Stent Graft System | TriVascular, Inc. Santa Rosa, CA 95403 |
Approval for an alternate delivery system sheath supplier. |
P120010/S008 3/13/14 Real-Time |
MiniMed 530G Insulin Pump | Medtronic Minimed Northridge, CA 91325 |
Approval for changes to the stack assemblies and battery tube assembly to comply with RoHS (Restriction of Hazardous Substances) requirements. These changes include changes to five components on the stack assembly, a change in material for the bare printed circuit boards (PCBs) of the stack assembly and battery tube assembly, and a change to the solder material (from Tin/Lead to Tin/Silver/Copper) used on the PCBs. |
P120019/S004 3/12/14 Real-Time |
cobas® EGFR Mutation Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for changes to the cobas® 4800 SR2 System software architecture and Assay Specific Analysis Package (ASAP) software for the cobas® BRAF V600 Mutation Test and cobas® EGFR Mutation Test. |
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 |
---|---|---|---|
N16837/S012 3/28/14 |
Artegraft Collagen Vascular Graft | Artegraft, Inc. North Brunswick, NJ 08902 |
Alternate supplier for the bovine carotid artery. |
P810002/S089 3/31/14 |
St. Jude Medical Mechanical Heart Valves and Valved Grafts | St. Jude Medical, Inc. St. Paul, MN 55117 |
Change to the pyrolytic carbon coating process. |
P820003/S127 3/26/14 |
SINGLE CHAMBER TEMPORARY PACEMAKER (AAI/VVI) AND DUAL CHAMBER TEMPORARY PACEMAKER | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the patient cable proximal connector. |
P820003/S128 3/12/14 |
SINGLE CHAMBER TEMPORARY PACEMAKER (AAI/VVI) AND DUAL CHAMBER TEMPORARY PACEMAKER | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P830061/S108 3/12/14 |
CapSure Sense, CapSure SP, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence PS+ Leads | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P840001/S262 3/19/14 |
RestorePrime Neurostimulator, PrimeAdvanced Neurostimulator, Itrel 4 Neurostimulator, Itrel 4 Neurostimulator |
Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Changes to the battery burn-in process and inspection methods. |
P850022/S021 3/26/14 |
Biomet OrthoPak Non-invasive Bone Growth Stimulator System & Biomet SpinalPak Non-invasive Spine Fusion Stimulator System |
EBI, LLC, d/b/a Biomet Spine & Bone Healing Technologies Parsippany, NJ 07054 |
Alternate-secondary supplier. |
P850089/S107 3/12/14 |
CapSure SP Novus, CapSure SP Z, CapSure Z Novus, Vitatron Impulse II Leads | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P860047/S028 3/28/14 |
OcuCoat Ophthalmic Viscosurgical Device | Bausch & Lomb, Inc. Irvine, CA 92618 |
Use of a new pouch sealer for the packaging process of OcuCoat Ophthalmic Viscosurgical device. |
P860057/S119 3/14/14 |
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change in the polyester cloth manufacturing aid. |
P860057/S120 3/27/14 |
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Alternate supplier of hydrogen peroxide. |
P870056/S065 3/14/14 |
Carpentier-Edwards Porcine Aortic and Mitral Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change in the polyester cloth manufacturing aid. |
P870056/S066 3/27/14 |
Carpentier-Edwards Porcine Aortic and Mitral Bioprostheses | Edwards Lifesciences, LLC Irvine, CA 92614 |
Alternate supplier of hydrogen peroxide. |
P870072/S059 3/18/14 |
Thoratec Ventricular Assist Device (VAD) System | Thoratec Corporation Pleasanton, CA 94588 |
Reduction in post-sterilization heated aeration time for some components. |
P870077/S059 3/14/14 |
Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis with Extended Suture Ring; Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Change in the polyester cloth manufacturing aid. |
P870077/S060 3/27/14 |
Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis with Extended Suture Ring, Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Alternate supplier of hydrogen peroxide. |
P880086/S239 3/4/14 |
Accent DR; Accent; Accent SR PM; Accent SR RF; Identity ADx DC; Identity ADx DR; Identity ADx XL DR; Identity DR; Identity XL DR; Identity ADx SR; Identity SR; Identity ADx VDR; Sustain XL DC; Sustain XL DR; Sustain X; Sustain XL SR; Verity ADx XL DC; Verity ADx XL DR; Verity ADx XL DR M/S; Verity; Verity ADx XL SR; Verity ADx XL SR M/S; Verity ADx XL VDR; Victory XL DR; Victory DR; Victory SR; Zephyr XL DR; Zephyr DR; Zephyr XL SR; Zephyr SR |
St. Jude Medical, Court Sylmar, CA 91342 |
Change in the wire bond process verification frequency utilized for the hybrid assemblies of the devices. |
P890003/S303 3/12/14 |
CapSure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P900056/S133 3/26/14 |
Rotablator Rotational Atherectomy System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to add a new ethylene oxide sterilization chamber. |
P900061/S128 3/12/14 |
Epicardial Patch Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P910023/S329 3/4/14 |
Fortify Assura VR; Ellipse VR; Fortify Assura DR ICDs | St. Jude Medical Sylmar, CA 91342 |
Implement changes to the parylene removal process used during ICD and CRT-D manufacture. |
P910023/S330 3/4/14 |
CURRENT , ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES | St. Jude Medical, Court Sylmar, CA 91342 |
Change in the wire bond process verification frequency utilized for the hybrid assemblies of the devices. |
P910023/S332 3/6/14 |
CURRENT , ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES | St. Jude Medical, Sylmar, CA 91342 |
Alternate supplier for the high voltage hybrid assemblies. |
P920015/S131 3/12/14 |
Sprint Quattro, Transvene CS/SVC Leads | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P920047/S066 3/26/14 |
Blazer II Cardiac Ablation Catheter and Cable | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to add a new ethylene oxide sterilization chamber. |
P930029/S041 3/13/14 |
RF Contactr Catheter, RF Enhancr II Catheter, RF Marinr Catheter, RF Conductr Catheter | Medtronic, Inc. Mounds View, MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
P930029/S042 3/12/14 |
RF Contactr Catheter, RF Enhancr II Catheter, RF Marinr Catheter, RF Conductr Catheter | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P930038/S072 3/21/14 |
Angio-SealTM Vascular Closure Device | St. Jude Medical Plymouth, MN 55442 |
Alternative to batch testing for bacterial endotoxin testing (BET). |
P930039/S105 3/12/14 |
CapSure Fix, CapSureFix Novus, SureFix, Vitatron Crystalline Leads | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P930039/S106 3/20/14 |
CapSureFix Novus Lead | Medtronic CRDM Mounds View MN, 55112 |
Additional laser for the electrode ring to coil weld operation for the devices. |
P950024/S059 3/12/14 |
CapSure Epicardial Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P950029/S089 3/20/14 |
Reply SR, Reply DR, Esprit SR , Esprit DR | Sorin CRM USA Arvada, CO 80004 |
Change in the gluing process for the setscrew caps, x-ray tag and connection block cavities. |
P960009/S189 3/19/14 |
Activa PC Neurostimulator, Activa SC Neurostimulator, Activa SC Neurostimulator |
Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Changes to the battery burn-in process and inspection methods. |
P960040/S309 3/12/14 |
PUNCTUA, TELEIGEN, ENERGEN, INCEPTA ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier for the can capacitor component. |
P960040/S311 3/31/14 |
INCEPTA, ENERGEN, PUNCTUA, TELIGEN Family of ICDs | Boston Scientific St. Paul, MN 55112 |
Alternate process for excising the printed circuit boards (PCB) from the PCB panel using a laser excise system. |
P960043/S087 3/20/14 |
Perclose ProGlide Suture Mediated Closure Device, Perclose AT 6F Suture Mediated Closure System |
Abbott Vascular, Inc. Santa Clara, CA 95054 |
Alternate supplier for the ePTFE fiber used in one of the components and minor associated manufacturing changes. |
P970003/S168 3/28/14 |
Cyberonics VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Make changes to the die packaging used in the creation of the Application Specific Integrated Circuit. |
P980003/S047 3/26/14 |
Chilli II Cooled Ablation Catheter and Cable | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to add a new ethylene oxide sterilization chamber. |
P980016/S464 3/4/14 |
Evera S DR/VR ICDs, Evera XT DR/VR ICDs, Maximo II ICDs, Protecta ICDs, Protecta XT ICDs, Secura ICDs | Medtronic CRDM Mounds View MN, 55112 |
Replacement of two (2) pick and place machines with one (1) new system used in hybrid manufacturing for the identified devices. |
P980016/S465 3/7/14 |
Evera S and Evera XT ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Change in the processing aid used in polytetrafluoro-ethylene (PTFE) production at a supplier. |
P980016/S466 3/5/14 |
Evera S DR/VR ICDs, Evera XT DR/VR ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Change in the crimping process for the feed through assembly used in the manufacture of selected Implantable Cardiac Defibrillators (ICD) and Cardioverter Resynchronization Therapy-Defibrillators (CRT-D). |
P980016/S467 3/12/14 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an inspection to the crimp height of the feedthrough pin for the devices. |
P980016/S469 3/12/14 |
Evera S DR/VR ICD, Evera XT DR/VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P980035/S367 3/12/14 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P980037/S041 3/5/14 |
AngioJet Rheolytic Thrombectomy System | MEDRAD, Inc./ Bayer Health Care Minneapolis, MN 55433 |
Modification to change the current manual method of quantifying the amount of bacterial endotoxins present to using an automated instrument. Additionally, the number of samples collected will be changed to three samples per sterile load, tested on a pooled basis and with explicit extraction instructions. |
P980050/S091 3/12/14 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P000007/S045 3/27/14 |
Edwards Prima Plus Stentless Porcine Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Alternate supplier of hydrogen peroxide. |
P000014/S027 3/10/14 |
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Addition of negative samples in the final release QC test, and an addition of the raw material combination test in the manufacture of the conjugate reagent. |
P000025/S076 3/26/14 |
COMBI 40+ Cochlear Implant System | MED-EL Elektro-Medizinische Geräte GmbH Fürstenweg Austria 77a |
Alternate component supplier. |
P000037/S035 3/18/14 |
On-X® Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78752 |
Change from manual etching to automated computer-controlled laser etching of serial numbers on components. |
P010012/S346 3/12/14 |
PUNCTUA, COGNIS, ENERGEN, INCEPTA CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier for the can capacitor component. |
P010012/S348 3/31/14 |
INCEPTA, ENERGEN, PUNCTUA, COGNIS Family of CRT-Ds | Boston Scientific St. Paul, MN 55112 |
Alternate process for excising the printed circuit boards (PCB) from the PCB panel using a laser excise system. |
P010013/S053 3/26/14 |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Change in the manufacturing process to allow the use of lead-free solder in the cable sub-assembly. |
P010015/S234 3/12/14 |
Attain Bipolar OTW Lead, Consulta CRT-P, Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P010029/S019 3/26/14 |
EUFLEXXA (1% Sodium Hyaluronate) |
Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 |
Introduction of a new thermoforming machine for secondary packaging. |
P010031/S426 3/4/14 |
Brava CRT-Ds, Concerto II CRT-Ds, Consulta ICDs, Maximo II CRT-Ds, Protecta CRT-Ds, Protecta XT CRT-Ds, Viva S CRT-Ds, Viva XT CRT-Ds | Medtronic CRDM Mounds View MN, 55112 |
Replacement of two (2) pick and place machines with one (1) new system used in hybrid manufacturing for the identified devices. |
P010031/S427 3/7/14 |
Brava, Viva S and Viva XT CRT-Ds | Medtronic, Inc Mounds View, MN 55112 |
Change in the processing aid used in polytetrafluoro-ethylene (PTFE) production at a supplier. |
P010031/S428 3/5/14 |
Brava CRT-Ds, Viva S CRT-Ds, Viva XT CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Change in the crimping process for the feed through assembly used in the manufacture of selected Implantable Cardiac Defibrillators (ICD) and Cardioverter Resynchronization Therapy-Defibrillators (CRT-D). |
P010031/S428 3/4/14 |
Brava, Viva S, and Viva XT Cardiac Resynchronization Therapy Defibrillators |
Medtronic, Inc. Mounds View, MN 55112 |
Change in the inspection and manufacturing processes in the cathode mix for the implantable pulse generator battery. |
P010031/S430 3/12/14 |
Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P010031/S429 3/12/14 |
Brava CRT-D, VIVA XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an inspection to the crimp height of the feedthrough pin for the devices. |
P010041/S048 3/14/14 |
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change in the polyester cloth manufacturing aid. |
P010041/S049 3/27/14 |
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Alternate supplier of hydrogen peroxide. |
P020009/S117 3/19/14 |
Express2™ Monorail® and OTW Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Eliminate the Pouch Seal Pull Test inspection in the Manual Final Packaging operation. |
P020009/S118 3/26/14 |
Express2 Monorail and OTW Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to add a new ethylene oxide sterilization chamber. |
P020009/S119 3/25/14 |
Express2 Monorail and OTW Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Add two additional Individual Molding Station (IMS) balloon molding towers in the Balloons Production area at the Maple Grove facility. |
P020025/S054 3/26/14 |
Blazer II XP Cardiac Ablation Catheter and Cable | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to add a new ethylene oxide sterilization chamber. |
P030002/S030 3/24/14 |
Crystalens Accommodating Intraocular Lens and Trulign Toric Posterior Chamber Intraocular Lens | Bausch & Lomb, Inc. Irvine, CA 92618 |
Additional haptic supplier be used. |
P030009/S075 3/19/14 |
Integrity Coronary Stent Systems | Medtronic Inc. Santa Rosa, CA 95403 |
Changes to how extruded components are physically grouped and to the way samples are selected for in-process testing. |
P030017/S190 3/7/14 |
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems | Boston Scientific Corporation Neuromodulation Valencia, CA 91355 |
Update test software. |
P030035/S117 3/4/14 |
Anthem; Anthem RF | St. Jude Medical, Court Sylmar, CA 91342 |
Change in the wire bond process verification frequency utilized for the hybrid assemblies of the devices. |
P030036/S071 3/12/14 |
Select Secure Leads | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P030054/S260 3/4/14 |
Unify Assura; Quadra Assura | St. Jude Medical Sylmar, CA 91342 |
Implement changes to the parylene removal process used during ICD and CRT-D manufacture. |
P030054/S261 3/14/14 |
Promote; Promote Accel; Promote RF; Promote Q CD; Promote Quadra; Promote+; Quadra Assura; Unify; Unify Assura; Unify Quadra |
St. Jude Medical, Court Sylmar, CA 91342 |
Change in the wire bond process verification frequency utilized for the hybrid assemblies of the devices. |
P030054/S263 3/6/14 |
Promote, Quadra, Unify CRT-Ds | St. Jude Medical, Sylmar, CA 91342 |
Alternate supplier for the high voltage hybrid assemblies. |
P040008/S008 3/6/14 |
VIDAS Total PSA (TPSA) Assay | BioMerieux, Inc. Louis, MO 63042 |
Addition of an alternate qualified supplier for the critical component: 4 and 8 mL capacity glass vials. |
P040016/S123 3/19/14 |
VeriFLEX™ (Liberté®) Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Eliminate the Pouch Seal Pull Test inspection in the Manual Final Packaging operation. |
P040016/S124 3/26/14 |
VeriFLEX (Liberté) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to add a new ethylene oxide sterilization chamber. |
P040016/S125 3/25/14 |
VeriFLEX (Liberte) Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Add two additional Individual Molding Station (IMS) balloon molding towers in the Balloons Production area at the Maple Grove facility. |
P040021/S025 4/2/14 |
Biocor™ and Epic™ Valve | St. Jude Medical St. Paul, MN 55117 |
Change to the incoming inspection plan for the polyester fabric component of the subject valves. |
P040034/S023 3/11/14 |
DuraSeal Dural Sealant System | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Addition of a new material supplier. |
P040047/S034 3/14/14 |
Coaptite Injectable Implant | Merz North America, Inc. Franksville, WI 53126 |
Implementation of in-house bioburden testing of the Coaptite product. |
P050028/S040 3/18/14 |
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/COBAS® TaqMan® HBV Test version 2.0 | Roche Molecular System, Inc. Pleasanton, CA 94588 |
Change to add a new supplier for an optional instrumentation component of the COBAS® AmpliPrep/ COBAS® TaqMan® system. |
P050037/S047 3/13/14 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Implementation of in-house bioburden testing of the Radiesse product. |
P050038/S020 3/12/14 |
ARISTA AH Absorbable Hemostat | Medafor, Inc. Minneapolis, MN 55429 |
Transfer of the distribution, warehouse facility and customer service ordering for finished devices. |
P050038/S021 3/19/14 |
ARISTA AH Absorbable Hemostat | Medafor, Inc. Minneapolis, MN 55429 |
Additional pouch sealer and an alternate packaging seal strength test method. |
P050052/S051 3/13/14 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Implementation of in-house bioburden testing of the Radiesse product. |
P060006/S055 3/19/14 |
Express™ SD Renal Monorail® Premounted Stent System | Boston Scientific Maple Grove, MN 55311 |
Eliminate the Pouch Seal Pull Test inspection in the Manual Final Packaging operation. |
P060006/S056 3/26/14 |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to add a new ethylene oxide sterilization chamber. |
P060006/S057 3/25/14 |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Maple Grove, MN 55311 |
Add two additional Individual Molding Station (IMS) balloon molding towers in the Balloons Production area at the Maple Grove facility. |
P060030/S039 3/4/14 |
COBAS® AmpliPrep/COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use with The High Pure System |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Update of the Calibration Test Definition File (TDF) used in the production of the COBAS AmpliPrep/COBAS TaqMan HCV Test and COBAS TaqMan HCV Test version 2.0 For Use with The High Pure System. |
P060030/S040 3/18/14 |
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System | Roche Molecular System, Inc. Pleasanton, CA 94588 |
Change to add a new supplier for an optional instrumentation component of the COBAS® AmpliPrep/ COBAS® TaqMan® system. |
P060033/S089 3/19/14 |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Inc. Santa Rosa, CA 95403 |
Changes to how extruded components are physically grouped and to the way samples are selected for in-process testing. |
P060034/S008 3/19/14 |
Bio-Rad MONOLISATM Anti-HBc IgM EIA | Bio-Rad Laboratories, Inc. Redmond, WA 98052 |
Addition of the Millrock Freeze Dryer to the list of approved equipment for lyophilizing the conjugate reagent final vials. |
P060038/S019 3/20/14 |
Mitroflow Aortic Pericardial Heart Valve | Sorin Group USA, Inc. Arvada, CO 80004 |
Change in the yarn supplier. |
P060039/S057 3/12/14 |
Attain StarFix Leads | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P060040/S032 3/18/14 |
Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 |
Reduction in post-sterilization heated aeration time for some components. |
P070014/S042 3/27/14 |
LIFESTENT Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Alternate equipment and automated process for the tantalum marker coining process. |
P070015/S120 3/10/14 |
XIENCE V® Everolimus Eluting Coronary Stent System on both RX (Rapid Exchange) and OTW (Over the Wire) Platforms and XIENCE nano™ Everolimus Eluting Coronary Stent System on the RX Platform | Abbott Vascular Temecula, CA 92590 |
Modifications to the sampling plan for the XIENCE final packaging oxygen content testing. |
P080006/S067 3/12/14 |
Attain Ability Leads | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P090013/S133 3/12/14 |
CapSureFix MRI Lead, Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Use of FACTORYworks Release 7.10 at several of Medtronic’s manufacturing facilities. |
P090013/S134 3/20/14 |
CapSureFix MRI Lead | Medtronic CRDM Mounds View MN, 55112 |
Additional laser for the electrode ring to coil weld operation for the devices. |
P100023/S088 3/14/14 |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate processes and equipment for the manufacturing and inspection of the distal tip of the delivery systems. |
P100023/S089 3/26/14 |
ION (Taxus Element) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to add a new ethylene oxide sterilization chamber. |
P100023/S090 3/25/14 |
ION (Taxus Element) Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Add two additional Individual Molding Station (IMS) balloon molding towers in the Balloons Production area at the Maple Grove facility. |
P100026/S013 3/24/14 |
Neuropace RNS System | NeuroPace, Inc. Mountain View, CA 94043 |
Add an alternate supplier for the cortical strip lead assembly. |
P100041/S048 3/10/14 |
Edwards Sapien Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change to the manufacturing process of the Crimper component for the 26 mm device size. |
P100041/S049 3/27/14 |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
Alternate supplier of hydrogen peroxide. |
P100047/S037 3/13/14 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Implementation of an alternate supplier for the non-patient contacting patch material used in the HeartWare® Ventricular Assist System. |
P100047/S038 3/13/14 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Implementation of a tool to be used as part of process monitoring during the manufacturing of the HVAD® Sewing Ring. |
P100047/S039 3/14/14 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Software changes to the equipment used for the surface texture and form measurements of components of the HeartWare Ventricular Assist Device Pump. |
P110003/S004 3/26/14 |
LeGoo | Genzyme, Corp. Framingham, MA 01701 |
Implementation of a modified LeGoo filling and inspection process for the 1.0 ml and 2.5 ml LeGoo syringes. |
P110006/S003 3/20/14 |
Invenia ABUS Automated Breast Ultrasound | GE Healthcare Wausatosa, WI 53226 |
Changes to include updating manufacturing documents, work instructions, and test procedures. Also, high level assembly of some subcomponents will be performed by Plexus Corporation. |
P110010/S075 3/13/14 |
Promus Element Plus/Promus Premier Everolimus-Eluting Coronary Stent Systems | Boston Scientific Maple Grove, MN 55311 |
Changes to the processing controls for packaging and labeling for the Promus Element Plus and Promus Premier Everolimus-Eluting Coronary Stent Systems. |
P110010/S076 3/14/14 |
Promus Element PlusTM / Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent Systems | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate processes and equipment for the manufacturing and inspection of the distal tip of the delivery systems. |
P110010/S077 3/26/14 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System |
Boston Scientific Corporation Maple Grove, MN 55311 |
Change to add a new ethylene oxide sterilization chamber. |
P110013/S035 3/14/14 |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Inc. Santa Rosa, CA 95403 |
Automating the parts of the stent coating weight processes. |
P110013/S036 3/19/14 |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Inc. Santa Rosa, CA 95403 |
Changes to how extruded components are physically grouped and to the way samples are selected for in-process testing. |
P110019/S064 3/10/14 |
XIENCE PRIME® (XIENCE PRIME and XIENCE PRIME Long Lengths [LL]) on the RX platform and XIENCE XPEDITION™ (Small Vessel [SV] and LL) on both RX and OTW platforms | Abbott Vascular Temecula, CA 92590 |
Modifications to the sampling plan for the XIENCE final packaging oxygen content testing. |
P110021/S035 3/10/14 |
Edwards Sapien Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change to the manufacturing process of the Crimper component for the 26 mm device size. |
P110021/S036 3/27/14 |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
Alternate supplier of hydrogen peroxide. |
P110037/S013 3/18/14 |
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test | Roche Molecular System, Inc. Pleasanton, CA 94588 |
Change to add a new supplier for an optional instrumentation component of the COBAS® AmpliPrep/ COBAS® TaqMan® system. |
P110042/S027 3/12/14 |
S-ICD® System | Cameron Health, Inc. San Clemente, CA 92672 |
Add a Field Effect Transistor saturation test at the supplier. |
P120006/S011 3/20/14 |
Ovation and Ovation Prime Abdominal Stent Graft Systems | TriVascular Inc. Santa Rosa, CA 95403 |
Extension of the hold time of stretched film in the manufacture of the retaining wrap. |
P120010/S010 3/6/14 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Addition of an alternate warehouse facility for the handling of raw materials including subassemblies and components for the MiniMed 530G Insulin Pump (MMT-551, MMT-751). The MiniMed 530G Insulin Pump is a component of the MiniMed 530G System. |
P120010/S011 3/20/14 |
MiniMed 530G System | Medtronic MiniMed, Inc. Northridge, CA 91325 |
Change in the manufacturing process for the EnliteTM Glucose. Sensor (Model Numbers: MMT-7008A, MMT-7008B) to add a new sensor fabrication configuration to include a 48-up sensor mask which will be manufactured by a new vendor. The EnliteTM Glucose Sensor is a component of the MiniMed 530G System. |
P120010/S012 3/21/14 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
New laser technology system to cut a rectangular window in the sensor tube for the Enlite sensor (MMT-7008A, MMT-7008B). The Enlite sensor is a component of the MiniMed 530G System. |
P120010/S013 3/26/14 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
New laser cutting program on the existing laser that is used during the sensor fabrication process. |
P120010/S015 3/31/14 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Change in the manufacturing process for the EnliteTM Glucose Sensor (Model Numbers: MMT-7008A, MMT-7008B) by adding an additional step during the assembly procedure and an inspection step during the packaging procedure. The EnliteTM Glucose Sensor is a component of the MiniMed 530G System. |
P130004/S004 3/25/14 |
ReSure Sealant | Ocular Therapeutix, Inc. Bedford, MA 01730 |
Change in the volume of diluent in the dropper bottle. |