Summary of PMA Originals & Supplements Approved
- Originals: 5
- Supplements: 72
Summary of PMA Originals Under Review
- Total Under Review: 47
- Total Active: 22
- Total On Hold: 25
Summary of PMA Supplements Under Review
- Total Under Review: 582
- Total Active: 449
- Total On Hold: 133
Summary of All PMA Submissions
- Received Originals: 1
- Supplements: 82
Summary of PMA Supplement PMA Approval/Denial Decision Times
- Number of Approvals: 72
- Number of Denials: 0
- Average Days Fr Receipt to Decision (Total Time): 137.7
- Days FDA Time: 98.6
- Days MFR Time: 39.1 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P130009 6/16/14 |
Edwards SAPIEN XT™ Transcatheter Heart Valve, model 9300TFX, 23, 26, and 29 mm, and accessories (NovaFlex+ delivery system, models 9355FS23, 9355FS26, and 9355FS29, with crimp stopper and Qualcrimp crimping accessory (laminated model or cloth model 9300QC); Edwards Expandable Introducer Sheath Set, models 916ES23, 918ES26, and 920ES29; Edwards balloon catheter, models 9350BC20, 9350BC23, and 9350BC25; Ascendra+ delivery system with crimp stopper, models 9355AS23, 9355AS26, and 9355AS29; Ascendra+ introducer sheath set, models 9350IS23, 9350IS26, and 9350IS29; Ascendra balloon aortic valvuloplasty catheter, model 9100BAVC; and Edwards crimper, model 9350CR) | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for the SAPIEN XT™ Transcatheter Heart Valve (THV), Model 9300TFX, and accessories. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, 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). |
| P130011 6/24/14 |
Freedom SOLO Stentless Heart Valve (sizes 21 mm, 23 mm, 25 mm, and 27 mm) and SOLO Smart Stentless Heart Valve (sizes 21 mm, 23 mm, 25 mm, and 27 mm) | Sorin Group Canada, Inc. Arvada, CO 80004 |
Approval for the Freedom SOLO Stentless Heart Valve and SOLO Smart Stentless Heart Valve. These devices are indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. |
| P130027 6/2/14 |
artus® CMV RGQ MDx Kit | QIAGEN, Inc. Gaithersburg, MD 20878 |
Approval for the artus® CMV RGQ MDx Kit. This device is indicated for: The artus® CMV RGQ MDx Kit is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma. The artus® CMV RGQ MDx Kit is intended for use as an aid in the management of solid organ transplant patients who are undergoing anti-CMV therapy. The test measures CMV DNA levels in EDTA plasma and can be used to assess CMV viral load response to antiviral drug therapy. The results from the artus® CMV RGQ MDx Kit must be interpreted within the context of all relevant clinical and laboratory findings. The artus® CMV RGQ MDx Kit is configured for use with the EZ1 DSP Virus System (EZ1 DSP Virus Kit and EZ1 Advanced instruments) for DNA extraction and the Rotor-Gene Q MDx instrument for CMV DNA amplification and quantitation. The artus® CMV RGQ MDx Kit is not intended for use as a screening test for blood or blood products. |
| P130029 6/17/14 |
Fluency® Plus Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Approval for the Fluency® Plus Endovascular Stent Graft. This device is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (AV) fistula or AV graft. |
| P130030 6/27/14 |
REBEL™ Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the REBEL™ Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire). This device is indicated for improving coronary luminal diameter in patients with de novo lesions ≤ 28 mm in length in native coronary arteries with a reference vessel diameter (RVD) of ≥ 2.25 to ≤ 4.50 mm. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N16895/S095 6/6/14 135-Day |
Bausch & Lomb SofLens® 38 (polymacon) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc. Rochester,NY 14609 |
Approval for a new UV bulb. |
| P840001/S260 6/4/14 135-Day |
SCS Neurostimulators Implantable Itrel Family, SCS Neurostimulators Implantable Restore Family, SCS Neurostimulators Implantable Synergy Family | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Approval for the implementation of a new oven for curing medical adhesive. |
| P910001/S071 6/30/14 Real-Time |
CVX-300 and CVX-300P Excimer Laser System | Spectranetics Corporation Colorado Springs, CO 80921 |
Approval for the addition of finger gaskets to the side radiation shields. |
| P910023/S331 6/20/14 Real-Time |
Ellipse DR/VR, Fortify DR/VR, Fortify Assura DR/VR ICDs | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for a change to the integrated circuit used in the manufacturing of the ICDs and CRT-Ds. |
| P910077/S140 6/20/14 180-Day |
Latitude NXT 2.0 Patient Management | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the LATITUDE NXT 2.0 Software for the Wave Communicator Model 6460, changes to the Wave Communicator 6280, approval of the Wave Communicator 6290, and updates to the communication software for Wave Communicator Models 6498 and 6476. |
| P950037/S131 6/20/14 Real-Time |
CYLOS, PHILOS, PHILOS II, EVIA, ENTOVIS, CURO, EFFECTA, AND ESTELLA PULSE GENERATORS | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for PSW 1306.U Programmer Software. |
| P960009/S188 6/4/14 135-Day |
DBS Neurostimulators Implantable Activa Family, DBS Neurostimulators Implantable Kinetra Family, DBS Neurostimulators Implantable Soletra Family | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Approval for the implementation of a new oven for curing medical adhesive. |
| P970004/S167 6/4/14 135-Day |
SNS Urinary Neurostimulators Implantable InterStim Family | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Approval for the implementation of a new oven for curing medical adhesive. |
| P980006/S018 6/3/14 180-Day |
PureVision® (balafilcon A) Contact Lens | Bausch & Lomb, Inc. Rochester, NY 14609 |
Approval for the revision of the labeling for the PureVision® (balafilcon A) Contact Lens to include the results of the Post-Approval Study. |
| P980016/S443 6/20/14 135-Day |
Evera S DR/VR ICD, Evera XT DR/VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Approval for Grommet and Medical Adhesive Rework Processes. |
| P980016/S481 6/20/14 Real-Time |
Protecta ICD and Protecta XT ICD | Medtronic, Inc. Mounds View, MN 55112 |
Approval for an updated version of the Protecta software, Model SW009 used on the 2090 Programmer and Encore Programmer Model 29901 for the devices. |
| P980040/S043 6/1/14 180-Day |
Tecnis Toric 1-Piece Intraocular Lens | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Approval of the post-approval study protocol. |
| P980049/S097 6/27/14 Real-Time |
Paradym RF VR, Paradym RF DR, Paradym VR, and Paradym DR ICDs |
Sorin CRM USA Arvada, CO 80004 |
Approval for embedded software changes for the devices and a revision to the Orchestra/Orchestra Plus Software Programming Module. |
| P980049/S098 6/27/14 Real-Time |
Paradym RF VR, Paradym RF DR ICDs | Sorin CRM USA Arvada, CO 80004 |
Approval for minor design changes to the SRAM and Zener Diodes for the devices. |
| P990012/S021 6/12/14 Real-Time |
Elecsys® HBsAg Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for release of cobas 8000 software version 04-01 and cobas 8000 Data Manager software version 1.03. |
| P990056/S021 6/12/14 Real-Time |
Elecsys® Total PSA Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for release of cobas 8000 software version 04-01 and cobas 8000 Data Manager software version 1.03. |
| P000009/S056 6/20/14 Real-Time |
LUMOS Implantable Cardioverter Defibrillators (ICDs) |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for PSW 1306.U Programmer Software. |
| P000020/S017 6/4/14 Real-Time |
Bard Ablation System | Boston Scientific Corporation Lowell, MA 01851 |
Approval for implementation of a change to lead-free solder in the connector component of the Stinger and Scorpion2 ablation catheters. |
| P000023/S009 6/2/14 Real-Time |
TMJ Fossa-Eminence and Condylar Prosthesis System | Nexus CMF, Limited Liability Company Salt Lake City, UT 84121 |
Approval for modifications to the bone screw length to match the labeled lengths, to standardize the screw thread profile and pitch, to increase the length of the threaded portion of the bone screw, to round the tip of the screw, to add a fillet between the screw head and screw shaft, to standardize dimensions of certain geometrical features of the bone screws (the screw head crown radius and driver slot depth), to standardize the minor diameter, and to introduce Ti-6Al-4V alloy bone screws. |
| P000025/S077 6/24/14 Real-Time |
MED-EL COMBI 40+ Cochlear Implant System; MAX Programming Interface & MAESTRO 5.0 Software |
MED-EL Corporation Durham, NC 27713 |
Approval for the MAX Programming Interface and the associated MAESTRO 5.0 programming software update. |
| P000027/S019 6/12/13 Real-Time |
Elecsys® Free PSA Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for release of cobas 8000 software version 04-01 and cobas 8000 Data Manager software version 1.03. |
| P000035/S009 6/2/14 Real-Time |
TMJ Fossa-Eminence Prosthesis System | Nexus CMF, Limited Liability Company Salt Lake City, UT 84121 |
Approval for modifications to the bone screw length to match the labeled lengths, to standardize the screw thread profile and pitch, to increase the length of the threaded portion of the bone screw, to round the tip of the screw, to add a fillet between the screw head and screw shaft, to standardize dimensions of certain geometrical features of the bone screws (the screw head crown radius and driver slot depth), to standardize the minor diameter, and to introduce Ti-6Al-4V alloy bone screws. |
| P000053/S050 6/16/14 180-Day |
AMS 800 Artificial Urinary Sphincter | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for modifications to the physician labeling to summarize the results of the INHIBIZONE® post-approval study. |
| P010031/S404 6/20/14 135-Day |
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Approval for Grommet and Medical Adhesive Rework Processes. |
| P010031/S443 6/20/14 Real-Time |
Protecta CRT-D and Protecta XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Approval for an updated version of the Protecta software, Model SW009 used on the 2090 Programmer and Encore Programmer Model 29901 for the devices. |
| P010054/S023 6/12/14 Real-Time |
Elecsys® Anti-HBs Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for release of cobas 8000 software version 04-01 and cobas 8000 Data Manager software version 1.03. |
| P020004/S092 6/20/14 Real-Time |
Gore Excluder AAA Endoprosthesis | W.L. Gore & Associates, Inc. Phoenix, AZ 85085 |
Approval for delivery system profile reduction (23, 26mm devices reduced from 18F to 16F), sleeve construct modifications, and delivery catheter modifications. |
| P020018/S022 6/4/14 Special |
Zenith AAA Endovascular Graft | Cook Medical Bloomington, IN 47402 |
Approval for updating the internal quality control for the Zenith AAA Endovascular Graft introduction system subassemblies by adding an additional inspection step to check for security of the tapered tip on the cannula. |
| P020055/S010 6/13/14 180-Day |
Ventana PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for addition of a new supplier for production of the bulk raw material and for a design change where the unpurified cell culture medium diluting the bulk raw material will switch from an RPMI-based solution to an E-RDF 5-based solution. |
| P030002/S028 6/27/14 180-Day |
Trulign Toric Posterior Chamber Intraocular Lens | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 |
Approval of the post-approval study protocol. |
| P030011/S020 6/26/14 180-Day |
SynCardia Freedom® Driver System | SynCardia Systems, Inc. Tucson, AZ 85713 |
Approval for the Freedom® Driver System. The device, as modified, will be marketed under the trade name SynCardia temporary Total Artificial Heart with the Freedom® Driver System and is indicated for use as a bridge to transplantation in cardiac transplant candidates who have been implanted with the TAH-t and are clinically stable. |
| P030011/S025 6/17/14 180-Day |
The Syncardia Freedom Driver System | Syncardia Systems, Inc. Tucson, AZ 85713 |
Approval of the post-approval study protocol. |
| P030017/S191 6/17/15 180-Day |
Infinion™ CX 16 Contact Lead Kit and Entrada™ Needle | Boston Scientific Neuromodulation (BSN) Corporation Valencia, CA 91355 |
Approval for the Infinion™ CX 16 Contact Lead Kit (Model SC-2317-xx) and Entrada™ Needle (Model SC-4220). |
| P030054/S262 6/20/14 Real-Time |
Quadra Assura, Unify, Unify Assura, Unify Quadra CRT-Ds | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for a change to the integrated circuit used in the manufacturing of the ICDs and CRT-Ds. |
| P040002/S046 6/18/14 135-Day |
AFX Endovascular AAA System (Bifurcated and Accessory Stent Graft Models) | Endologix, Inc. Irvine, CA 92618 |
Approval for a modified ePTFE graft wrapping manufacturing process. |
| P040003/S014 6/13/14 180-Day |
Exablate System | InSightec, Inc. Dallas, TX 75244 |
Approval for Post Approval Study labeling update. |
| P040012/S053 6/5/14 135-Day |
RX Acculink Carotid Stent System | Abbott Vascular Santa Clara, CA 95054 |
Approval for a change in the visual inspection criteria for bent struts for the RX Acculink Carotid Stent System. |
| P040024/S072 6/13/14 Panel-Track |
Restylane Silk Injectable Gel | Valeant Pharmaceuticals North America LLC/Medicis Bridgewater, NJ 08807 |
Approval for Restylane Silk. This device is indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21. |
| P040033/S026 6/17/14 Special |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Cordova, TN 38016 |
Approval to modify the language in the IFU and Patient Information Brochure: Remove BHR bridging cup (no longer marketed) editorial changes to contraindications section, warning and addition of preoperative precautions, and modification of the sterilization section. |
| P040043/S060 6/4/14 180-Day |
Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG Device) | W.L. Gore & Associate, Inc. Flagstaff, AZ 86001 |
Approval for a modification to the destructive testing sampling plan and change in the deployment force specification. |
| P040044/S054 6/17/14 Real-Time |
Mynx® Vascular Closure Device Product Family | Access Closure Santa Clara, CA 95054 |
Approval for design and manufacturing process changes to the O-ring component for the Mynx® Vascular Closure Device Product Family. |
| P050023/S072 6/20/14 Real-Time |
LUMAX, ILESTO, AND IFORIA Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for PSW 1306.U Programmer Software. |
| P050050/S006 6/3/14 Real-Time |
Scandinavian Total Ankle Replacement System (STAR Ankle) | Small Bone Innovations, Incorporated Morrisville, PA 19067 |
Approval for changing the inner pouch material for the STAR Sliding Core component. |
| P050044/S028 6/5/14 Real-Time |
Vitagel RT3 Surgical Hemostat | Stryker Orthobiologics Malvern, PA 19355 |
Approval for the following changes to the BA-02 Delivery System component of Vitagel RT3 Surgical Hemostat: replacement of the current syringe clip and syringe support components with a twin syringe dispenser, replacement of the current joiner component with a rotating luer adapter (syringe adapter) to the distal luer connections of the extended applicators, changes in materials of construction and manufacturers of the aforementioned components and update in the primary packaging. Additionally, the optional Extended Applicator delivery accessories of the Vitagel RT3 Surgical Hemostat, Malleable Extended Applicator (MEA) and Laparoscopic Extended Applicator (LEA), as modified, will be marketed under the trade names Reach 9 Malleable Applicator and Reach 38 Laparoscopic Applicator, respectively. |
| P060027/S064 6/27/14 Real-Time |
Paradym RF CRT-D and Paradym CRT-D |
Sorin CRM USA Arvada, CO 80004 |
Approval for embedded software changes for the devices and a revision to the Orchestra/Orchestra Plus Software Programming Module. |
| P060027/S065 6/27/14 Real-Time |
Paradym RF CRT-D | Sorin CRM USA Arvada, CO 80004 |
Approval for minor design changes to the SRAM and Zener Diodes for the devices. |
| P070008/S049 6/20/14 Real-Time |
STRATOS, EVIA, and ENTOVIS Cardiac Resynchronization Therapy Pacemakers | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for PSW 1306.U Programmer Software. |
| P080004/S015 6/16/14 Real-Time |
iSert® Gemetric™ Intraocular Lens (IOL) | Hoya Surgical Optics, Inc. Chino Hills, CA 91709 |
Approval for an optical design curvature modification to the iSert® Model 251 to add a controlled positive spherical aberration to the optic. The device, as modified, will be marketed under the trade name iSert® Gemetric™ Model 751 and is indicated for implantation after extracapsular cataract extraction or phacoemulsification of cataracts in adults. This lens is intended for placement in the capsular bag. |
| P080009/S001 6/16/14 180-Day |
SEDASYS ® Computer-Assisted Personalized Sedation System | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 | Approval for design modifications to the hardware, firmware, and software and a new manufacturing facility at FLEX Medical in Tijuana, Mexico. |
| P080025/S063 6/4/14 135-Day |
SNS Bowel Neurostimulators Implantable InterStim Family | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Approval for the implementation of a new oven for curing medical adhesive. |
| P080011/S029 6/3/14 180-Day |
CooperVision comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton CA 94588 |
Approval for new brand names Biofinity XR Toric and Biofinity XR Multifocal. |
| P080032/S015 6/17/14 180-Day |
The Alair Bronchial Thermoplasty System | Boston Scientific Corporation Marlborough, MA 01752 |
Approval for a manufacturing site located at Stellartech Research Corporation, in Milpitas, California. |
| P090008/S013 6/12/14 Real-Time |
Elecsys® Anti-HCV Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for release of cobas 8000 software version 04-01 and cobas 8000 Data Manager software version 1.03. |
| P090022/S020 6/16/14 180-Day |
Softec HD Posterior Chamber Intraocular Lens (IOL), Pre-Loaded Injector (PLI) System | Lenstec Inc. St. Petersburg, FL 33716 |
Approval to allow for the distribution of an alternate packaging of the Pre-Loaded Injector (PLI) Tips in a 12-pack carton. |
| P090022/S022 6/16/14 Real-Time |
Softec HD, Softec I, and Softec HDO Posterior Chamber Intraocular Lenses (PCIOL) | Lenstec Inc. St. Petersburg, FL 33716 |
Approval to reduce the size of the secondary packaging which houses the pouched intraocular lenses, label and directions for use (DFU). The device, as modified, will be marketed under the trade name Softec HD, Softec I, and Softec HDO and is indicated for the replacement of the human crystalline lens following phacoemulsificaton cataract removal in adults over the age of 21. |
| P100005/S004 6/6/14 Real-Time |
M-Vu® Algorithm Engine | VuCOMP, Inc. Plano, TX 75093 |
Approval for M-Vu® Algorithm Engine version 3.1.0.0 with shorter execution time. |
| P100009/S001 6/13/14 180-Day |
Mitral Valve Repair and Clip Delivery Systems (MitraClip®) | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Approval of the post-approval study protocol. |
| P100031/S011 6/12/14 Real-Time |
Elecsys® Anti-HBc Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for release of cobas 8000 software version 04-01 and cobas 8000 Data Manager software version 1.03. |
| P100041/S044 6/11/14 135-Day |
Edwards SAPIENTM Transcatheter Heart Valve and Transfemoral Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval to automate label printing, implement new peel strength equipment, and relocate manufacturing Radio-Frequency Identification tags. |
| P100046/S004 6/13/14 180-Day |
Atricure Synergy Ablation System | Atricure, Inc. West Chester, OH 45069 |
Approval of the post-approval study protocol. |
| P100047/S044 6/27/14 Special |
HeartWare Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Approval for updates to the Instructions for Use and Patient Manual of the device to include information related to battery performance. |
| P110001/S011 6/4/14 180-Day |
RX Herculink Elite Renal Stent System | Abbott Vascular Santa Clara, CA 94086 |
Approval for a labeling update based on the post-approval study results. |
| P110002/S002 6/3/14 180-Day |
Mobi-C Cervical Disc | LDR Spine USA Austin, TX 78750 |
Approval of the post-approval study protocol. |
| P110019/S048 6/2/14 Real-Time |
XIENCE PRIME® and XIENCE PRIME® Long Lengths Everolimus-Eluting Coronary Stent Systems; XIENCE XPEDITION™, XIENCE XPEDITION™ Small Vessel and XIENCE XPEDITION™ Long Lengths Everolimus-Eluting Coronary Stent Systems |
Abbott Vascular, Inc. Temecula, CA 92591 |
Approval to modify the in vitro drug release specifications for the devices. |
| P110021/S031 6/11/14 135-Day |
Edwards SAPIENTM Transcatheter Heart Valve and Transfemoral and Transapical Accessories |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval to automate label printing, implement new peel strength equipment, and relocate manufacturing Radio-Frequency Identification tags. |
| P110022/S012 6/12/14 Real-Time |
Elecsys® Anti-HBc IgM Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for release of cobas 8000 software version 04-01 and cobas 8000 Data Manager software version 1.03. |
| P110023/S006 6/22/14 180-Day |
EverFlexTM Self-Expanding Peripheral Stent System | ev3, Inc. Plymouth, MN 55441 |
Approval for updated labeling that includes 3-year clinical outcomes. |
| P110042/S039 6/27/14 Special |
SQ-RX Pulse Generator, Q-TRAK Electrode and Q-GUIDE Electrode Insertion Tool (EIT) |
Cameron Health, Inc. San Clemente, CA 92673 |
Approval for adding language in the implant manuals of the referenced devices which states and clarifies that good tissue contact with the electrode and pulse generator is important for optimizing sensing and therapy delivery. |
| P120005/S011 6/3/14 180-Day |
Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System | Dexcom Inc. San Diego, CA 92121 |
Approval for the G4 PLATINUM Professional Continuous Glucose Monitoring System, that includes the Dexcom G4 Platinum Professional Receiver Shield, to allow multiple patient use of the system by a healthcare professional. The device, as modified, will be marketed under the trade name G4 PLATINUM Professional Continuous Glucose Monitoring System and is indicated for: The Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for multiple patient use and requires purchase by a healthcare provider. The system is not intended for use in a hospital setting. The Dexcom G4 PLATINUM Professional System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The Dexcom G4 PLATINUM Professional System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the G4 PLATINUM Professional System results should be based on the trends and patterns seen with several sequential readings over time. |
| P120010/S016 6/3/14 Real-Time |
MiniMed 530G System | Medtronic Minimed Northridge, CA 91325 |
Approval for changes to the software to the MiniMed 530G Insulin Pump (Models MMT-551 and MMT-751). These changes include corrections for two motor error anomalies and three threshold suspend anomalies, and enhancements for the threshold suspend feature, insulin value setting, and merged common code base. |
| P120010/S019 6/18/14 Real-Time |
MiniMed 530G System | Medtronic Minimed Northridge, CA 91325 |
Approval for changes to the Enlite™ Glucose Sensor (MMT-7008A, MMT-7008B) of the MiniMed 530G System. Specifically, the supplement requested design modifications to the needle hub and needle carrier components of the Enlite sensor to fit the automation machine that will be used for the sensor assembly. Additionally, the new manufacturing process will take place in the Juncos, Puerto Rico manufacturing site. |
| P130021/S002 6/12/13 Panel-Track |
Medtronic CoreValve™ system (MCS): Transcatheter Aortic Valve (TAV); CoreValve™ Evolut™); Delivery Catheter System (DCS); and Compression Loading System (CLS) | Medtronic CoreValve LLC Santa Rosa, CA 95403 |
Approval for the Medtronic CoreValve™ system. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6 cm2/m2, a mean aortic valve gradient of ≥40 mm Hg, or a peak aortic-jet velocity of ≥4.0 m/s) and with native anatomy appropriate for the 23, 26, 29, or 31 mm valve system 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). |
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 |
|---|---|---|---|
| N17600/S029 6/26/14 |
Avitene Microfibrillar Collagen Hemostat Product | Davol, Inc Warwick, RI 02886 |
Foil pouch supplier facility site change and the proposed removal of a rejection criterion for component acceptance in an in-process inspection step for the Avitene product family. |
| P800002/S021 6/26/14 |
Avitene Microfibrillar Collagen Hemostat Product | Davol, Inc Warwick, RI 02886 |
Foil pouch supplier facility site change and the proposed removal of a rejection criterion for component acceptance in an in-process inspection step for the Avitene product family. |
| P830055/S145 6/5/14 |
Sigma Rotating Platform Total Knee System and Attune Rotating Platform Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46582 |
Introduce a new vacuum sealer. |
| P840001/S269 6/27/14 |
SCS Neurostimulators Implantable Itrel Family; SCS Neurostimulators Implantable Restore Family;SCS Neurostimulators Implantable Synergy Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add an alternate supplier for a component of the battery. |
| P860004/S207 6/7/14 |
Drug Delivery Infusion Pumps SynchroMed Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add an alternate supplier for a component of the battery. |
| P860057/S125 6/18/14 |
Carpentier-Edwards PERIMOUNT Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Expansion of a clean room at the Edwards Singapore manufacturing facility and the addition of associated equipment for use in the existing clean room. |
| P880086/S243 6/25/14 |
Accent; Verity; Identity; Zephyr; Assurity+; Assurity; Endurity CRT-P’s | St. Jude Medical Sylmar, CA 91342 |
Add an alternate supplier for the identical epoxy used in the manufacture of the devices. |
| P890003/S310 6/30/14 |
Prodigy IPG | Medtronic CRDM Mounds View, MN 55112 |
Minor changes to the battery manufacturing process. |
| P890057/S022 6/2/14 |
3100 HFOV High Frequency Oscillating Ventilator | CareFusion Yorba Linda, CA 92887 |
Change to the diaphragm cap assembly. |
| P910007/S045 6/18/14 |
ARCHITECT Total PSA | Abbott Laboratories, Abbott Park, IL 60064 |
Changes to the quality control testing of ARCHITECT Free PSA Panels G/I, ARCHITECT Total PSA Panel Stock and ARCHITECT Total PSA Panels K/Q. |
| P910023/S337 6/25/14 |
Current; Fortify; Fortify Assura; Ellipse ICD’s | St. Jude Medical Sylmar, CA 91342 |
Add an alternate supplier for the identical epoxy used in the manufacture of the devices. |
| P910023/S338 6/18/14 |
Fortify; Fortify Assura | St. Jude Medical Sylmar, CA 91342 |
Add a visual inspection step for the manufacture process of the devices. |
| P910073/S126 6/30/14 |
ENDOTAK RELIANCE DF1/IS-1 and ENDOTAK RELIANCE 4-SITE Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Add the Model 6946 Lead Repair Kit to the list of devices to be sterilized in the G8 #3 sterilization chamber. |
| P930039/S109 6/17/14 |
CapSureFix Lead | Medtronic Inc. Mounds View MN, 55112 |
Minor change to the plasma treatment and spooling process used on silicone tubing which is used as insulation in the impacted lead model. |
| P950037/S134 6/30/14 |
SLX, SELOX, DEXTRUS, SAFIO Leads | BIOTRONIK, Inc. Lake Oswega, OR 97035 |
Changes to the in-process quality inspection criteria for the devices. |
| P96000/S195 6/27/14 |
DBS Neurostimulators Implantable Activa Family; DBS Neurostimulators Implantable Kinetra Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add an alternate supplier for a component of the battery. |
| P960040/S317 6/2/14 |
NG3 Implantable Cardioverter Defibrillator (ICD); ORIGEN ™ EL ICD; INOGEN ™ EL ICD; DYNAGEN ™ EL ICD; NG2.5 Implantable Cardioverter Defibrillator (ICD) ORIGEN ™ MINI ICD; INOGEN ™ MINI ICD; DYNAGEN ™ MINI ICD |
Boston Scientific Corporation St. Paul, MN 55112 |
Modify the plasma clean process. |
| P960040/S318 6/17/14 |
DYNAGEN™ Family of ICDs; INOGEN™ Family of ICDs; ORIGEN™ Family of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Add the Model SE600 Solder Print Inspection (SPI) System as part of the manufacture process for the devices. |
| P970004/S173 6/10/14 |
SNS Urinary Neurostimulator Implantable InterStim Family | Medtronic Neuromodulation Minneapolis, MN 55432 |
Acceptance of manufacturing changes/process changes at two locations intended to improve the manufacturing processes to increase the assurance that the Model 3531 Verify ENS and the Model 3537 Controller will perform as expected. |
| P970004/S174 6/19/14 |
SNS Urinary Neurostimulator Implantable InterStim Family | Medtronic Neuromodulation Minneapolis, MN 55432 |
Acceptance of two manufacturing changes/process changes to the Model 3537 Controller. |
| P970004/S175 6/27/14 |
SNS Urinary Neurostimulator Implantable InterStim Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add an alternate supplier for a component of the battery. |
| P970013/S059 6/25/14 |
Microny CRT-P’s | St. Jude Medical Sylmar, CA 91342 |
Add an alternate supplier for the identical epoxy used in the manufacture of the devices. |
| P970051/S120 6/17/14 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Acceptance of alternate solder material. |
| P980003/S051 6/27/14 |
Chilli Cooled Ablation Catheter | Boston Scientific Corporation San Jose, CA 95134 |
Change in manufacture of the Chilli II catheter where a powered braid removal fixture will replace the manual preparation of the proximal shaft. |
| P980007/S036 6/18/14 |
ARCHITECT Free PSA | Abbott Laboratories, Abbott Park, IL 60064 |
Changes to the quality control testing of ARCHITECT Free PSA Panels G/I, ARCHITECT Total PSA Panel Stock and ARCHITECT Total PSA Panels K/Q. |
| P980016/S484 6/17/14 |
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; Virtuoso II DR/VR ICD |
Medtronic CRDM Mounds View, MN 55112 |
Improvements for the plasma cleaning process at the manufacturing site at Medtronic Puerto Rico Operations (MPROC) for the devices. |
| P980016/S485 6/18/14 |
Evera S DR/VR ICD, Evera XT DR/VR ICD | Medtronic CRDM Mounds View, MN 55112 |
Update to the equipment software for the Case-to-Cover (CTC) laser weld process. |
| P980023/S058 6/30/14 |
KAINOX, LINOX Leads | BIOTRONIK, Inc. Lake Oswega, OR 97035 |
Changes to the in-process quality inspection criteria for the devices. |
| P980035/S377 6/2/14 |
Adapta, Versa, Sensia IPG | Medtronic CRDM Mounds View, MN 55112 |
Replace the existed oven with a new Infrared Cure oven for the Dadet curing process at the final device manufacturing facility for the devices. |
| P980035/S378 6/17/14 |
Adapta, Versa, Sensia; Advisa DR IPG; Advisa DR MRI IPG; Relia IPG | Medtronic CRDM Mounds View, MN 55112 |
Improvements for the plasma cleaning process at the manufacturing site at Medtronic Puerto Rico Operations (MPROC) for the devices. |
| P980035/S379 6/30/14 |
Adapta, Versa, Sensia, and Relia IPG | Medtronic CRDM Mounds View, MN 55112 |
Minor changes to the battery manufacturing process. |
| P990038/S020 6/27/14 |
ETI-MAK-2 PLUS | DiaSorin Incorporated Stillwater, MN 55082 |
Change to the in-process QC procedure for a raw material. |
| P990041/S019 6/27/14 |
ETI-AB-EBK PLUS | DiaSorin Incorporated Stillwater, MN 55082 |
Change to the in-process QC procedure for a raw material. |
| P990042/S016 6/27/14 |
ETI-AB-AUK PLUS | DiaSorin Incorporated Stillwater, MN 55082 |
Change to the in-process QC procedure for a raw material. |
| P990043/S020 6/27/14 |
ETI-EBK PLUS | DiaSorin Incorporated Stillwater, MN 55082 |
Change to the in-process QC procedure for a raw material. |
| P990044/S017 6/27/14 |
ETI-CORE-IGMK PLUS | DiaSorin Incorporated Stillwater, MN 55082 |
Change to the in-process QC procedure for a raw material. |
| P990045/S017 6/27/14 |
ETI-AB-COREK PLUS | DiaSorin Incorporated Stillwater, MN 55082 |
Change to the in-process QC procedure for a raw material. |
| P000040/S032 6/10/14 |
Genesys HTA System | Boston Scientific Corporation Marlborough, MA 01752 |
Qualify an alternate secondary supplier of the tackifier resins used in the production of the coatings used on sheath and cassette tray Tyvek lids. |
| P000046/S024 6/24/14 |
Staarvisc, Optivisc, NuVisc and Anikavisc Sodium Hyaluronate | Anika Therapeutics, Inc. Bedford, MA 01730 |
Change to the quality control method for reduced testing for Anika’s ophthalmic devices: Staarvisc, Optivisc, Nuvisc, and Anikavisc Sodium Hyaluronate at the postfill stage. |
| P010012/S356 6/2/14 |
NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT-D); 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 |
Modify the plasma clean process. |
| P010012/S357 6/7/14 |
DYNAGEN™ Family of CRT-Ds; INOGEN™ Family of CRT-Ds; ORIGEN™ Family of CRT-Ds |
Boston Scientific Corporation St. Paul, MN 55112 |
Add the Model SE600 Solder Print Inspection (SPI) System as part of the manufacture process for the devices. |
| P010013/S056 6/4/14 |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Change to update the procedure for External Sheath, Cervical Collar and IMD Assembly. |
| P010013/S057 6/19/14 |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Manufacturing process change to add an additional zig-zag stitch to the current array liner and array sewing assembly process. |
| P010030/S050 6/6/14 |
Lifevest Wearable Cardioverter Defibrillator Models WCD 4000 and WCD 3000 |
Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Change to the acceptance criteria of refurbished battery packs. |
| P010031/S446 6/17/14 |
Brava CRT-D; Concerto II CRT-D; Consulta ICD; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva S CRT-D; Viva XT CRT-D |
Medtronic CRDM Mounds View, MN 55112 |
Improvements for the plasma cleaning process at the manufacturing site at Medtronic Puerto Rico Operations (MPROC) for the devices. |
| P010031/S447 6/18/14 |
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic CRDM Mounds View, MN 55112 |
Update to the equipment software for the Case-to-Cover (CTC) laser weld process. |
| P010032/S080 6/27/14 |
EON MINI AND PROGEGE Implantable Neurostimulation Device-Octrode Leads | St. Jude Medical Plano, TX 75024 |
Implement changes to the testing and inspection process. |
| P020004/S095 6/18/14 |
EXCLUDER AAA Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
Implementation of an auto-twist feature to the constraining loop manufacturing process. |
| P020004/S096 6/20/14 |
EXCLUDER AAA Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
New temperature control units on existing molding machines for catheter components. |
| P020004/S097 6/30/14 |
EXCLUDER AAA Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
Expansion of the process range for a catheter bond. |
| P020009/S124 6/30/14 |
Express2 Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the stent laser cutting and inspection process. |
| P020036/S029 6/13/14 |
SMART and SMART Control Nitinol Stent Systems | Cordis Corporation Fremont, CA 94555 |
Implementation of a new ultrasonic welder to be used by the supplier of the hemostasis valve of the slider assembly. |
| P030017/S196 6/4/14 |
Precision Spectra Spinal Cord Stimulator System | Boston Scientific Corporation Valencia, CA 91355 |
Add an alternate qualified supplier for the printed circuit board. |
| P030017/S197 6/6/14 |
Precision Spectra Spinal Cord Stimulator System | Boston Scientific Corporation Valencia, CA 91355 |
Change to the supplier’s facility location. |
| P030017/S199 6/6/14 |
Precision and Precision Spectra™ Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Neuromodulation Valencia, CA 91355 |
Alternate qualified supplier for mixing the two-part epoxy. |
| P030019/S019 6/12/14 |
Orthovisc, High Molecular Weight Hyaluronan | Anika Therapeutics, Incorporated Bedford, MA 01730 |
Changes to the quality control method. |
| P030035/S121 6/25/14 |
Anthem, Allure CRT-P’s | St. Jude Medical Sylmar, CA 91342 |
Add an alternate supplier for the identical epoxy used in the manufacture of the devices. |
| P030054/S269 6/25/14 |
Promote+; Unify; Unify Assura; Unify Quadra CRT-D’s | St. Jude Medical Sylmar, CA 91342 |
Add an alternate supplier for the identical epoxy used in the manufacture of the devices. |
| P030054/S270 6/18/14 |
Unify; Unify Assura; Unify Quadra CRT-D’s | St. Jude Medical Sylmar, CA 91342 |
Add a visual inspection step for the manufacture process of the devices. |
| P040016/S130 6/30/14 |
VeriFLEX (Liberte) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the stent laser cutting and inspection process. |
| P040024/S074 6/25/14 |
Restylane, Perlane, Restylane-L, and Perlane-L Injectable Gels | Valeant Pharmaceuticals North America Bridgewater, NJ 08807 |
Introduction of a second supplier for ready prepared solutions used in the manufacture of the Restylane Injectable Gels. |
| P040037/S064 6/18/14 |
GORE® VIABAHN® Endoprosthesis | W.L. Gore and Associates, Inc. Flagstaff, AZ 86005 |
Addition of elements of automation to the existing Quality Control Testing for heparin activity. |
| P040037/S065 6/20/14 |
VIABAHN Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
New temperature control units on existing molding machines for catheter components. |
| P040043/S062 6/20/14 |
TAG Thoracic Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
New temperature control units on existing molding machines for catheter components. |
| P040047/S035 6/19/14 |
Coaptite Injectable Implant | Merz North America, Inc. Franksville, WI 53126 |
Changes to the assembly process for the syringes used for the Coaptite Injectable Implant. |
| P050037/S049 6/19/14 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Changes to the assembly process for the syringes used with the Radiesse Dermal Filler. |
| P050039/S016 6/18/14 |
Novation Ceramic Articulation Hip System (AHS) | Exactech, Incorporated Gainesville, FL 32653 |
Change in a quality control test parameter:Changes to the bioburden alert limit and the verification dose. |
| P050047/S038 6/24/14 |
Juvcderm Hyaluronate Gel Implants and Juvederm Voluma XC | Allergan Goleta, CA 93117 |
Implementation of a new incoming warehouse and a cold room for the storage of raw materials and packaging items. |
| P050052/S054 6/19/14 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Changes to the assembly process for the syringes used with the Radiesse Dermal Filler. |
| P060006/S061 6/30/14 |
Express SD Renal Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the stent laser cutting and inspection process. |
| P060022/S019 6/12/14 |
Akreos Intraocular Lens | Bausch & Lomb, Inc. Irvine, CA 92618 |
Addition of a Getinge Steam sterilizer for the sterilization of Akreos Intraocular Lenses. |
| P070008/S051 6/30/14 |
COROX, CELERITY Leads | BIOTRONIK, Inc. Lake Oswega, OR 97035 |
Changes to the in-process quality inspection criteria for the devices. |
| P070014/S046 6/17/14 |
Bard LifeStent Vascular Stent | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Optional process for transferring a stent to a new delivery system catheter. |
| P080025/S069 6/10/14 |
SNS Bowel Neurostimulators Implantable InterStim Family | Medtronic Neuromodulation Minneapolis, MN 55432 |
Acceptance of manufacturing changes/process changes at two locations intended to improve the manufacturing processes to increase the assurance that the Model 3531 Verify ENS and the Model 3537 Controller will perform as expected. |
| P080025/S070 6/19/14 |
SNS Bowel Neurostimulators Implantable InterStim Family | Medtronic Neuromodulation Minneapolis, MN 55432 |
Acceptance of two manufacturing changes/process changes to the Model 3537 Controller. |
| P080025/S071 6/27/14 |
SNS Bowel Neurostimulators Implantable InterStim Family | Medtronic Neuromodulation Minneapolis, MN 55432 |
Add an alternate supplier for a component of the battery. |
| P090003/S033 6/30/14 |
Express LD Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the stent laser cutting and inspection process. |
| P090013/S143 6/17/14 |
Revo MRI IPG | Medtronic CRDM Mounds View, MN 55112 |
Improvements for the plasma cleaning process at the manufacturing site at Medtronic Puerto Rico Operations (MPROC) for the devices. |
| P090031/S001 6/6/14 |
Monovisc Injectable Intra-articular Device | Anika Therapeutics, Incorporated Bedford, MA 01730 |
Add an alternate raw material supplier. |
| P100023/S099 6/3/14 |
ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Natick, MA 01760 |
Change to the heat shrink removal process for the stent delivery catheters. |
| P100023/S100 6/3/14 |
ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Remove the manual inspection of the distance between the bi-component assembly (bond) and proximal balloon bond. |
| P100023/S101 6/30/14 |
ION (Taxus Element) Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the stent laser cutting and inspection process. |
| P100026/S018 6/18/14 |
Neuropace RNS System | NeuroPace, Inc. Mountain View, CA 94043 |
Add additional testing equipment. |
| P100047/S042 6/11/14 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Update to the welding process at Harding Energy, Inc for the nickel metal hydride battery used in the device Controller. |
| P100047/S043 6/13/14 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Corrections to specific test scripts run by the battery test equipment. |
| P100049/S009 6/11/14 |
LINX Reflux Management System | Torax Medical, Inc. Shoreview, MN 55126 |
Introduction of new tensile testers to be used during LINX device manufacturing. |
| P110004/S004 6/2/14 |
NIRxcell CoCr Coronary Stent on RX System | Medinol Ltd. Tel-Aviv, Israel 61581 |
Shortening of the supply chain for the Nylon 12 raw material used in the coating of a component of the D-catheter delivery system. |
| P110004/S006 6/4/14 |
NIRxcell™ CoCr Coronary Stent on RX | Medinol Ltd. Tel Aviv, Israel 61581 |
Eliminating a redundant inspection step and removing an unnecessary labeling step. |
| P110010/S086 6/4/14 |
PROMUS Element™ Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Remove the manual inspection of the distance between the bi-component assembly (bond) and proximal balloon bond. |
| P110010/S087 6/3/14 |
PROMUS Element Plus™ and PROMUS PREMIER™ Everolimus Eluting Platinum Chromium Coronary Stent Systems | Boston Scientific Corporation Natick, MA 01760 |
Change to the heat shrink removal process for the stent delivery catheters. |
| P110010/S088 6/30/14 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System / Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Natick, MA 01760 |
Change to the stent laser cutting and inspection process. |
| P110033/S008 6/10/14 |
Juvéderm Voluma XC | Allergan Goleta, CA 93117 |
Change to the unit of measurement for gel to be mixed and a change to the in process concentration of the lidocaine solution mixed into the gel during homogenization. |
| P110033/S009 6/24/14 |
Juvcderm Hyaluronate Gel Implants and Juvederm Voluma XC | Allergan Goleta, CA 93117 |
Implementation of a new incoming warehouse and a cold room for the storage of raw materials and packaging items. |
| P110038/S005 6/11/14 |
Relay Thoracic Stent-Graft with Plus Delivery System | Bolton Medical, Inc. Sunrise, FL 33325 |
Alternate supplier for fabric processing. |
| P110042/S037 6/27/14 |
Subcutaneous Implantable Defibrillator (S-ICD) System | Boston Scientific CRM St. Paul, MN 55112 |
New battery flex forming fixture. |
| P120002/S004 6/13/14 |
SMART and SMART Control Vascular Stent Systems | Cordis Corporation Fremont, CA 94555 |
Implementation of a new ultrasonic welder to be used by the supplier of the hemostasis valve of the slider assembly. |
| P120005/S020 6/18/14 |
Dexcom G4™ PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Change to increase the manufacturing space to support new Clean Environment and Material Transfer rooms for G4 PLATINUM Sensor/Applicators. |
| P120005/S021 6/30/14 |
Dexcom G4 PLATINUM Continuous Glucose Monitoring System | Dexcom Inc. San Diego, CA 92121 |
Addition of warehouse space. |
| P130006/S004 6/18/14 |
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface | W.L. Gore and Associates, Inc. Flagstaff, AZ 86005 |
Addition of elements of automation to the existing Quality Control Testing for heparin activity. |
| P130006/S005 6/20/14 |
VIABAHN Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
New temperature control units on existing molding machines for catheter components. |
| P130008/S001 6/9/14 |
INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems Inc. Maple Grove, MN 55369 |
Additional assembly process be added. |
| P130015/S001 6/6/14 |
Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg | Roche Diagnostics Indianapolis, IN 46250 |
Changes to the in-process test procedure for the bulk positive control and to the manufacturing process for filling of the streptavidin coated beads. |
| P130016/S006 6/17/14 |
Nucleus 24 Hybrid System | Cochlear Americas Centennial, CO 80111 |
Acceptance of alternate solder material. |
