Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 43
Summary of PMA Originals Under Review
Total Under Review: 52
Total Active: 23
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 582
Total Active: 394
Total On Hold: 188
Summary of All PMA Submissions Received
Originals: 0
Supplements: 54
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 43
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 185
FDA Time: 123.9 Days MFR Time: 61.1 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P130004 1/8/14 |
ReSure® Sealant | Ocular Therapeutix, Inc. Bedford, MA 01730 |
Approval for the ReSure® Sealant. This device is indicated for intraoperative management of clear corneal incisions (up to 3.5mm) with a demonstrated wound leak for which a temporary dry surface can be achieved, in order to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens (IOL) placement in adults. |
| P130021 1/17/14 |
Medtronic CoreValve™ System (MCS): Transcatheter Aortic Valve (TAV), Models MCS-P4-23-AOA (23 mm; CoreValve™ Evolut™), MCS-P3-26-AOA (26 mm), MCS-P3-29-AOA (29 mm), and MCS-P3-31-AOA (31 mm); Delivery Catheter System (DCS), Models DCS-C4-18FR and DCS-C4-18FR-23; and Compression Loading System (CLS), Model CLS-3000-18FR | 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 ≤ 0.8 cm2, a mean aortic valve gradient of > 40 mmHg, or a peak aortic-jet velocity of > 4.0 m/s) and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity ≥50% at 30 days). |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P830055/S138 1/22/14 135-Day |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for changes to device identifiers and part identification verification processes. |
| P860004/S184 1/8/14 180-Day |
Clinician Programmer, Telemetry Head, Synchromed III Implantable Programmable Infusion Pump, Synchromed II Implantable Programmable Infusion Pump | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the release of a Clinical Summary for Synchromed II Clinical Accuracy. |
| P860057/S116 1/24/14 180-Day |
Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Approval of the post-approval study protocol. |
| P890003/S290 1/22/14 Real-Time |
CapSure VDD-2 Leads | Medtronic, Inc. Mounds View, MN 55112 |
Approval for use of new silicone insulation tubing materials. |
| P890055/S053 1/22/14 Special |
MedStream™ Programmable Infusion System; MedStream™ Control Unit; MedStream™ Refill Kit; MedStream™ Bolus Kit; CODMAN® Operating Room Prep Kit | Codman & Shurtleff, Incorporated 325 Paramount Drive, Raynham, MA 02767 |
Approval for addition of a 100% inspection to verify the Use by Date on the labels of the MedStream Implantable Infusion Pump System. |
| P910001/S065 1/14/14 180-Day |
CVX-300 4.0 and CVX-300 4.0P Excimer Laser System | Spectranetics Corporation Colorado Springs, CO 80921 |
Approval for new circuitry and optical components to improve control of the regulated energy output of the CVX-300 laser generator. |
| P920015/S122 1/22/14 Real-Time |
Lead Adaptor | Medtronic, Inc. Mounds View, MN 55112 |
Approval for use of new silicone insulation tubing materials. |
| P950005/S047 1/22/14 Real-Time |
Celsius FLTR Bi-directional Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for manufacturing and design changes to the catheter tip. |
| P960043/S083 1/16/14 135-Day |
Perclose ProGlide®/Perclose AT® Suture Mediated Closure Systems and Snared Knot Pusher | Abbott Vascular Inc. Santa Clara, CA 95054 |
Approval for the use of an internal facility as an additional supplier of three extruded components. |
| P970029/S025 1/28/14 180-Day |
Holmium Laser System Fiber Optic Delivery System Handpiece | Cardiogenesis Corporation Kennesaw, GA 30144 |
Approval of the post-approval study protocol. |
| P970051/S094 1/21/14 180-Day |
Nucleus Cochlear Implant System: Cochlear Integrity Test System | Cochlear Americas Centenial, CO 80111 |
Approval for the Cochlear Integrity Test System (CITS). |
| P980022/S133 1/15/14 180-Day |
Paradigm Real-Time System, Paradigm Real-Time Revel System | Medtronic MiniMed Northridge, CA 91325 |
Approval for the reduction of keypad button (dome) sizes, new keypad overlay supplier (Bergquist), and keypad/ overlay/ case assembly process for the Paradigm REAL-Time Insulin Pumps (Models: MMT-522, MMT-522K, MMT-722, MMT-722K and Paradigm REAL-Time Revel Insulin Pumps (Models: MMT-523, MMT-523K, MMT-723, and MMT-723K) that are components of the Paradigm REAL-Time and Paradigm REAL-Time Revel Systems, respectively. |
| P980023/S054 1/17/14 135-Day |
Linox, Linoxsmart, Vigila, and Volta ICD leads | Biotronik Lake Oswega, OR 97035 |
Approval for an alternate supplier for shock coils used in the subject leads. |
| P000025/S072 1/10/14 135-Day |
COMBI 40+ Cochlear Implant System (Mi1000 MED-EL CONCERT and SONATATI100) | MED-EL Elektro-Medizinische Geräte GmbH Innsbruck – Fürstenweg, Austria 77a |
Approval for an alternate welding process. |
| P010005/S007 1/29/14 180-Day |
ProstaLund CoreTherm® Accessories for Small Prostates CoreTherm Catheter Short (CA804120); Microwave Antenna Short (AN806101); and lntraprostatic Temperature Probe Short (IP807101) | ProstaLund Operations AB Uppsala, Sweden SE-751 06 |
Approval for modification of the indications for use and associated modifications to the catheter, antenna, and temperature probe for patients with prostates smaller than currently indicated. The device, as modified, will be marketed under the trade name CoreTherm® Accessories for Small Prostates and is indicated for use together with ProstaLund CoreTherm® /SE in patients with glands size 20-50g and with a prostate length ≥25 mm. |
| P010068/S036 1/22/14 Real-Time |
Celsius FLTR Uni-directional Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for manufacturing and design changes to the catheter tip. |
| P030027/S007 1/3/14 135-Day |
Ceramic TRANSCEND® Articulation System | Wright Medical Technology, Inc. Arlington, TN 38002 |
Approval for changing the incoming inspection process of components from the supplier. |
| P030052/S012 1/24/14 180-Day |
UroVysion Bladder Cancer Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for a manufacturing site located at Leica Biosystems in Solon Mills, Illinois. |
| P040002/S044 1/24/14 Real-Time |
AFX Endovascular AAA System with Vela Proximal Endograft Delivery System | Endologix, Inc. Irvine, CA 92618 |
Approval for dimensional modification of the inner core of the AFX Vela Proximal Endograft Delivery System. |
| P040045/S041 1/16/14 180-Day |
VISTAKON (senofilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Approval for a change in the viscosity specification from 120-170 cps to 100-170 cps for the reactive monomer mix. |
| P050007/S031 1/16/14 135-Day |
StarClose SE® Vascular Closure System | Abbott Vascular Inc. Santa Clara, CA 95054 |
Approval for the use of an internal facility as an additional supplier of three extruded components. |
| P050023/S073 1/17/14 Real-Time |
Lumax 300 and 500 Families of ICD’s and CRT-D’s | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for a modification of the land pad geometry for the high voltage diodes on the substrate. |
| P050044/S027 1/27/14 135-Day |
Vitagel RT Surgical Hemostat (Vitagel RT3 Surgical Hemostat) | Stryker Orthobiologics Malvern, PA 19355 |
Approval of the transfer of sterility testing of Vitagel RT3 filled syringes inhouse. |
| P060008/S107 1/21/14 180-Day |
Drug-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval of the post-approval study protocol. |
| P060029/S005 1/17/14 180-Day |
Ethicon OMNEX Surgical Sealant | Ethicon, Inc. Somerville, NJ 08876 |
Approval for a manufacturing site located at Ethicon, Inc., in Cornelia, Georgia. |
| P070014/S041 1/22/14 Special |
LifeStent Vascular Stent System | C.R. Bard, Inc. Tempe, AZ 85281 |
Approval for an additional labeling verification inspection method for the device packaging. |
| P080007/S019 1/22/14 Special |
E-Luminexx Vascular Stent System | C.R. Bard, Inc. Tempe, AZ 85281 |
Approval for an additional labeling verification inspection method for the device packaging. |
| P090006/S009 1/22/14 135-Day |
Complete SE Vascular Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for multiple stent processing changes for the Complete SE Vascular Stent System. |
| P100009/S002 1/28/14 180-Day |
Mitral Valve Repair and Clip Delivery Systems (MitraClip®) | Abbott Vascular, Inc. Menlo Park, CA 94025 |
Approval of the post-approval study protocol. |
| P100014/S009 1/14/14 180-Day |
Solesta | Salix Pharmaceuticals, Inc. Raleigh, NC 27615 |
Approval for the revision of the prescribing information to include 24 and 26 month data. |
| P100021/S027 1/24/14 180-Day |
Endurant Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval of the post-approval study protocol. |
| P100040/S012 1/22/14 Panel-Track |
Valiant Thoracic Stent Graft with Captivia Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the Valiant Thoracic Stent Graft with Captivia Delivery System (Valiant Captivia). This device is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having the appropriate anatomy including: 1) iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices or accessories; nonaneurysmal aortic diameter in the range of 18 mm to 42 mm (fusiform and saccular aneurysms/ penetrating ulcers), or 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 mm to 44 mm (dissections); and nonaneurysmal aortic proximal and distal neck lengths ≥ 20 (fusiform and saccular aneurysms/ penetrating ulcers), landing zone ≥20 mm proximal to the primary entry tear (blunt traumatic aortic injuries, dissections). The proximal extent of the landing zone must not be dissected. |
| P100040/S013 1/7/14 Real-Time |
Valiant Thoracic Stent Graft System with Captivia Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a product line extension consisting of the addition of 11 Valiant Freeflo Tapered Stent Grafts. The device, as modified, will be marketed under the trade name Valiant Thoracic Stent Graft System with Captivia Delivery System and is indicated for the endovascular repair of isolated lesions (excluding dissections) of the descending thoracic aorta in patients having appropriate anatomy, including: iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories; nonaneurysmal aortic diameter in the range of 18 to 42 mm (fusiform and saccular aneurysms/ penetrating ulcers) or 18 mm to 44 mm (blunt traumatic aortic injuries); and nonaneurysmal aortic proximal and distal neck lengths ≥ 20 mm. |
| P100041/S037 1/31/14 135-Day |
SAPIEN™ Transcatheter Heat Valve and Transfemoral Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for a change in material to the mandrels used as manufacturing aids for the delivery system. |
| P100044/S012 1/31/14 180-Day |
Propel Mini Sinus Implant | Intersect ENT Menlo Park, CA 94025 |
Approval to revise the release rate specification. |
| P100044/S013 1/9/14 Real-Time |
Propel® Mini Sinus Implant | Intersect ENT Menlo Park, CA 94025 |
Approval for a design modification to the Delivery System Accessory component of the previously approved Propel Mini Sinus Implant. |
| P110012/S004 1/24/14 180-Day |
Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for a manufacturing site located at Leica Biosystems in Solon Mills, Illinois. |
| P110013/S028 1/30/14 180-Day |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic, Inc. Santa Rosa, CA 95403 |
Approval for modifications to the Resolute Integrity Zotarolimus-Eluting Coronary Stent System Instructions for Use (IFU) to include updated clinical information. |
| P110019/S055 1/14/14 Real-Time |
XIENCE Xpedition Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92589 |
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 12 to 24 months. |
| P110019/S058 1/7/14 180-Day |
XIENCE Xpedition Stent System | Abbott Vascular Temecula, CA 92589 |
Approval for a manufacturing site located in North Brunswick, New Jersey. |
| P110021/S024 1/31/14 |
SAPIEN™ Transcatheter Heart Valve and Transfemoral and Transapical Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for a change in material to the mandrels used as manufacturing aids for the delivery system. |
| P110028/S011 1/16/14 135-Day |
Absolute Pro® Vascular Self-Expanding Stent System | Abbott Vascular Temecula, CA 92591 |
Approval for a change to the stent sub-assembly cleaning process that occurs prior to the electropolish process. |
| P110042/S020 1/31/14 180-Day |
Subcutaneous Implantable Defibrillator S-ICD System | Cameron Health, Inc. San Clemente, CA 92673 |
Approval for a new battery supplier for the SQ-RX Model 1010 Implantable Pulse Generator. |
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 |
|---|---|---|---|
| P800002/S020 1/14/14 |
Avitene Microfibrillar Collagen Hemostat Product | Davol, Inc. Warwick, RI 02886 |
Add a new supplier for the blister tray used for the Avitene Microfibrillar Collagen Hemostat-Endo Avitene product. |
| P810006/S050 1/17/14 |
Collastat Absorbable Collagen Hemostatic Sponge | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Change to introduce an alternate test method for bacterial endotoxin in collagen products. |
| P830061/S102 1/8/14 |
CAPSURE Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software. |
| P820003/S126 1/16/14 |
Single and Dual Temporary Pacemakers | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P830061/S104 1/16/14 |
CapSure Sense, CapSure SP, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence PS+ Leads | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P830061/S105 1/16/14 |
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead | Medtronic CRDM Mounds View MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P840001/S259 1/22/14 |
SCS Accessories; SCS Extensions; Hinged 2×4 Surgical Lead; Vectris SureScan 1×8 Leads; Pisces Leads; Resume Leads; Lead Revision Kits; Specify Leads; Trialing System Screening Cable; Vectris 1×8 trialing Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change associated with incoming inspection activities. |
| P840062/S037 1/17/14 |
CollaCote and CollaTape Absorbable Collagen Wound Dressings for Dental Surgery | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Change to introduce an alternate test method for bacterial endotoxin in collagen products. |
| P850010/S049 1/17/14 |
Helistat Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Change to introduce an alternate test method for bacterial endotoxin in collagen products. |
| P850089/S104 1/16/14 |
CapSure SP Novus, CapSure SP Z, CapSure Z Novus, Vitatron impulse II Leads | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P850089/S105 1/16/14 |
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead | Medtronic CRDM Mounds View MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P860057/S117 1/23/14 |
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change in the polyester cloth manufacturing aid. |
| P870056/S064 1/23/14 |
Carpentier-Edwards Porcine Aortic and Mitral Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change in the polyester cloth manufacturing aid. |
| P870077/S058 1/23/14 |
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. |
| P890003/S294 1/9/14 |
MyCareLink Patient Monitor, MyCareLink Reader FRU | Medtronic, Inc. Mounds View, MN 55112 |
Process change for the MyCareLink Monitor Solder Process. |
| P890003/S298 1/16/14 |
CapSure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P890003/S300 1/16/14 |
MyCareLink Patient Monitor and Reader FRU | Medtronic CRDM Mounds View, MN 55112 |
Change in the test equipment/test method used in the quality control inspection process of the printed circuit board assemblies used in the MyCareLink Patient Monitor. |
| P890003/S301 1/16/14 |
CapSure Lead | Medtronic CRDM Mounds View MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P890055/S052 1/15/14 |
MedStream Programmable Infusion System | Codman & Shurtleff, Inc. Raynham, MA 02767 |
New steam sterilizer. |
| P900056/S130 1/30/14 |
Rotablator Rotational Atherectomy System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the long drive laser welder equipment used in the RotaLink long drive sub-assembly line. |
| P900061/S126 1/16/14 |
Epicardial Patch Lead | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P910001/S069 1/14/14 |
ELCA Coronary Atherectomy Catheters | Spectranetics Corporation Colorado Springs, CO 80921 |
Modifications to reduce the frequency of sterile barrier strength testing and a modification to the process of seal strength monitoring. |
| P920015/S127 1/16/14 |
Sprint Quattro, Transvene CS/SVC Leads | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P920015/S128 1/16/14 |
Sprint Quattro Lead, HV Splitter/Adaptor Kit | Medtronic CRDM Mounds View MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P930014/S070 1/9/14 |
AcrySof Intraocular Lens | Alcon Research, Ltd. Fort Worth, TX 76134 |
Use of a new aberrometer. |
| P930014/S071 1/13/14 |
AcrySof Monofocal Posterior Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Reduce frequency of a manufacturing inspection from a 100% inspection rate to a sample-based inspection plan for devices within a lot. |
| P930029/S040 1/16/14 |
RF Marinr MC (7fr), RF Marinr (5fr), RF Contactr, RF Conductr, Rf, Enhancr II | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P930039/S098 1/8/14 |
CAPSUREFIX Novus Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software. |
| P930039/S101 1/16/14 |
CapSure Fix, CapSureFix Novus, SureFix, Vitatron Crystalline Leads | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P930039/S102 1/16/14 |
CapSureFix Novus Lead, Vitatron Crystalline Lead | Medtronic CRDM Mounds View MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P950005/S049 1/24/14 |
Celsius, Celsius RMT, EZ Steer Non-Temp sensing Ablation Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change in the sterilization release method for Biosense Webster catheters and cables. |
| P950024/S056 1/16/14 |
CapSure Epicardial Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P950024/S057 1/16/14 |
CapSure Epicardial Pacing Lead | Medtronic CRDM Mounds View, MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P950037/S133 1/6/14 |
Selox ST 53, Selox ST 60, Selox JT 45,Selox JT 53, Setrox S 45, Setrox S 53, Setrox S 60, Dextrus 4135, Dextrus 4136, Detrus 4137 Pacing Leads | Biotronik, Inc. Lake Oswego, OR 97035 |
Two additional injection molding tools used to manufacture the silicone sleeves of the pacemaker leads. |
| P950039/S027 1/29/14 |
ThinPrep Processor 2000/3000 | Hologic, Inc. Marlborough, MA 01752 |
Addition of a specification on minimum cell transfer requirements for the ThinPrep Microscope Slides. |
| P960009/S187 1/22/14 |
DBS Accessories; DBS Extensions; DBS Leads; DBS Screening Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change associated with incoming inspection activities. |
| P960042/S047 1/14/14 |
Spectranetics Laser Sheaths SLS | Spectranetics Corporation Colorado Springs, CO 80921 |
Modifications to reduce the frequency of sterile barrier strength testing and a modification to the process of seal strength monitoring. |
| P960043/S085 1/29/14 |
Perclose Proglide® and Perclose AT® Suture Mediated Closure Systems | Abbott Vascular Inc. Santa Clara, CA 95054 |
Change to the joint tensile testing process. |
| P960043/S086 1/30/14 |
Perclose ProGlide Suture Mediated Closure Device and Perclose AT 6F Suture Mediated Closure System | Abbott Vascular Inc. Santa Clara, CA 95054 |
Additional testing apparatus and procedure be included in the functional testing performed on the Gated Suture Trimmer. |
| P960058/S105 1/8/14 |
HiResolution Bionic Ear System | Advanced Bionics Sylmar, CA 91342 |
Use of a new sterilization cycle. |
| P970003/S167 1/2/14 |
Cyberonics VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Replace the capacitor used in the assembly of the printed circuit boards for the Programming Wand. |
| P970004/S166 1/22/14 |
SNS Urinary Extensions; SNS Urinary Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change associated with incoming inspection activities. |
| P970012/S094 1/16/14 |
Application Software, Remote Assistant | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| N970012/S098 1/2/14 |
AMS 700 Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 |
Proposed addition of an alternative method (automated) for applying a plug to the kink resistant tubing during the manufacturing application of an antimicrobial surface treatment. |
| P980016/S453 1/16/14 |
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 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P980035/S356 1/8/14 |
ADAPTA, VERSA, SENSIA Implantable Pulse Generators | Medtronic, Inc. Mounds View, MN 55112 |
Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software. |
| P980035/S359 1/16/14 |
Adapta, Versa, Sensia IPG, Advisa DR/DR MRI IPG, Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P980035/S361 1/22/14 |
Adapta, Versa, Sensia IPG; Advisa DR IPG;. Advisa DR MRI IPG; Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
New supplier for the molding compound used in the manufacturing of capacitors for the hybrid assemblies. |
| P980035/S362 1/16/14 |
Advisa DR IPG, Advisa DR MRI IPG | Medtronic CRDM Mounds View, MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P980044/S017 1/14/14 |
SUPARTZ Joint Fluid Therapy | Seikagaku Corporation Tokyo, Japan 100-0005 |
Contract laboratory change. |
| P980050/S089 1/16/14 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P980050/S090 1/16/14 |
Transvene CS/SVC Lead | Medtronic CRDM Mounds View, MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P990001/S116 1/16/14 |
Vita VVIR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P990025/S039 1/24/14 |
NaviStar, NaviStar RMT, EZ Steer Nay Catheters and BWI Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change in the sterilization release method for Biosense Webster catheters and cables. |
| P990038/S019 1/10/14 |
ETI-MAK-2 PLUS and HBsAg Confirmatory Test | DiaSorin Inc. Stillwater, MN 55082 |
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples. |
| P990041/S018 1/10/14 |
ETI-AB-EBK PLUS | DiaSorin Inc. Stillwater, MN 55082 |
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples. |
| P990042/S015 1/10/14 |
ETI-AB-AUK PLUS | DiaSorin Inc. Stillwater, MN 55082 |
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples. |
| P990043/S019 1/10/14 |
ETI-EBK PLUS | DiaSorin Inc. Stillwater, MN 55082 |
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples. |
| P990044/S016 1/10/14 |
ETI-CORE-IGMK PLUS | DiaSorin Inc. Stillwater, MN 55082 |
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples. |
| P990045/S016 1/10/14 |
ETI-AB-COREK PLUS | DiaSorin Inc. Stillwater, MN 55082 |
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples. |
| P990046/S037 1/24/14 |
Open Pivot Heart Valve and Aortic Valve Graft | Medtronic Inc. CardioVascular Mounds View, MN 55112 |
Alternative to batch testing for bacterial endotoxin testing (BET). |
| P990071/S025 1/24/14 |
RF Generator and Accessories/Accessory Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change in the sterilization release method for Biosense Webster catheters and cables. |
| P990081/S025 1/22/14 |
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Addition of a new supplier for PCBAs (Printed Circuit Board Assemblies) used in the manufacture of the BenchMark ULTRA Instrument. |
| P990081/S026 1/23/14 |
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Addition of a new supplier for a subassembly used in the manufacture of the BenchMark XT Instrument. |
| P000006/S035 1/17/14 |
Titan Inflatable Penile Prosthesis | Coloplast Corp Minneapolis, MN 55411 |
Change to the mold used in the manufacture of the connector sleeve. |
| P000012/S047 1/9/14 |
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/COBAS® AMPLICOR® HCV Test version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change to discontinue chemical testing for potassium concentration in master mixes. |
| P000025/S074 1/17/14 |
COMBI 40+ Cochlear Implant System (Mi1000 MED-EL CONCERT and SONATATI100) | MED-EL Elektro-Medizinische Geräte GmbH Innsbruck – Fürstenweg 77a Austria A-6020 |
Changes in the vacuum bake-out process and the preparation of in-process test samples. |
| P000046/S021 1/24/14 |
Staarvisc, Optivisc, and Anikavisc Sodim Hyaluronate | Anika Therapeutics, Inc. Bedford, MA 01730 |
Change to the manufacturing process with regard to the device’s packaging. |
| P000046/S022 1/23/14 |
Staarvisc II, Shellgel | Anika Therapeutics, Inc. Bedford, MA 01730 |
Addition of a new cannula supplier. |
| P000053/S049 1/2/14 |
AMS 800 Urinary Control | American Medical Systems, Inc. Minnetonka, MN 55343 |
Proposed addition of an alternative method (automated) for applying a plug to the kink resistant tubing during the manufacturing application of an antimicrobial surface treatment. |
| P010015/S228 1/16/14 |
Attain Bipolar OTW Lead, Consulta CRT-P, Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P010015/S230 1/22/14 |
Consulta CRT-P, Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
New supplier for the molding compound used in the manufacturing of capacitors for the hybrid assemblies. |
| P010015/S231 1/16/14 |
Attain Bipolar OTW Lead, Consulta CRT-P, Left Ventricular Pacing Lead, Syncra CRT-P | Medtronic CRDM Mounds View, MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P010030/S047 1/22/14 |
LifeVest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
New supplier for the therapy electrode gas generator base and therapy electrode gas generator enclosure cover. |
| P010031/S415 1/16/14 |
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 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P010033/S023 1/31/14 |
QuantiFERON®-TB Gold | Cellestis Incorporated Valencia, CA 91355 |
Changes to incorporate new branding in the labeling, tighten an in-process QC specification for the blood collection tubes, and add steps to a raw material acceptance procedure. |
| P010041/S047 1/23/14 |
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change in the polyester cloth manufacturing aid. |
| P010047/S033 1/27/14 |
Progel Pleural Air Leak Sealant | Neomend Inc. Irvine, CA 92618 |
Addition of a second source component supplier. |
| P010068/S038 1/24/14 |
Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change in the sterilization release method for Biosense Webster catheters and cables. |
| P020004/S089 1/17/14 |
GORE® EXCLUDER® AAA Endoprosthesis | W.L. Gore and Associates, Inc. Flagstaff, AZ 86005 |
Alternate PTFE resin. |
| P020009/S114 1/29/14 |
Express2 Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Remove the metals content load test used for the monitoring of electropolishing solutions. |
| P020055/S013 1/23/14 |
Pathway Anti-c-KIT (9.7) Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Addition of a new supplier for a subassembly used in the manufacture of the BenchMark XT Instrument. |
| P030009/S073 1/14/14 |
Integrity Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Change to the bioburden test method. |
| P030017/S187 1/22/14 |
Precision Spectra Spinal Cord Stimulator System | Boston Scientific Corporation Canyon Loop Valencia, CA 91355 |
Add an alternate qualified supplier for the printed circuit board assembly. |
| P030017/S188 1/22/14 |
Precision Spectra Spinal Cord Stimulator System | Boston Scientific Corporation Canyon Loop Valencia, CA 91355 |
Add an alternate qualified supplier for the feedthrough component. |
| P030022/S028 1/13/14 |
Reflection Ceramic Acetabular Hip System | Smith & Nephew, Incorporated Memphis, TN 38116 |
Change to a different detergent chelating agent. |
| P030022/S029 1/13/14 |
Reflection Ceramic Acetabular Hip System (RCHS) | Smith & Nephew, Incorporated Memphis, TN 38116 |
Add new manufacturing equipment. |
| P030031/S058 1/24/14 |
Celsius ThermoCool, Celsius RMT ThermoCool Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change in the sterilization release method for Biosense Webster catheters and cables. |
| P030036/S068 1/16/14 |
Select Secure Leads | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P030036/S069 1/16/14 |
SelectSecure Lead | Medtronic CRDM Mounds View, MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P030050/S019 1/23/14 |
SCULPTRA and SCULPTRA AESTHETIC | Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 |
Changes to the sieving yield range and a modification of the stirring system for clogging test. |
| P040016/S120 1/29/14 |
VeriFLEX (Liberte) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Remove the metals content load test used for the monitoring of electropolishing solutions. |
| P040020/S052 1/13/14 |
AcrySof ReSTOR Multifocal Posterior Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Reduce frequency of a manufacturing inspection from a 100% inspection rate to a sample-based inspection plan for devices within a lot. |
| P040036/S041 1/24/14 |
NaviStar-, Navistar RMT-, EZ Steer- ThermoCool Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change in the sterilization release method for Biosense Webster catheters and cables. |
| P040044/S050 1/24/14 |
Mynx Vascular Closure Device Product Family, MynxGrip and MynxAce | Access Closure Inc. Santa Clara, CA 95054 |
Changes to the Hydrogel drying process. |
| P050028/S038 1/9/14 |
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change to discontinue chemical testing for potassium concentration in master mixes. |
| P050028/S039 1/23/14 |
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/COBAS® TaqMan® HBV Test version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change to discontinue in-process testing for pH and visual inspection for a vialed component. |
| P050034/S012 1/15/14 |
Implantable Miniature Telescope | VisionCare Ophthalmic Technologies Petah Tikva, Israel 49130 |
Possibility of rework and retesting activities. |
| P050051/S025 1/9/14 |
ARCHITECT AUSAB | Abbott Laboratories Abbott Park, IL 60064 |
Change to the purification process for antigens used in the manufacture of the ARCHITECT AUSAB assay. |
| P060006/S053 1/29/14 |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Remove the metals content load test used for the monitoring of electropolishing solutions. |
| P060030/S038 1/9/14 |
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 |
Change to discontinue chemical testing for potassium concentration in master mixes. |
| P060033/S085 1/14/14 |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to the bioburden test method. |
| P060039/S054 1/16/14 |
Attain StarFix Leads | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P060039/S055 1/16/14 |
Attain StarFix Lead | Medtronic CRDM Mounds View, MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P070004/S007 1/8/14 |
Sientra Silicone Gel Breast Implants | Sientra, Inc. Santa Barbara, CA 93117 |
Changes to the material of the breast implant molds. |
| P070015/S118 1/8/14 |
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 XIENCE final release testing. |
| P070027/S037 1/14/14 |
Talent AAA Stent Graft with Xcelerant Hydro Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to the bioburden test method. |
| P080006/S064 1/16/14 |
Attain Ability Leads | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P080006/S065 1/16/14 |
Attain Ability Lead | Medtronic CRDM Mounds View, MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P080025/S062 1/22/14 |
SNS Bowel Extensions; SNS Bowel Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change associated with incoming inspection activities. |
| P090003/S030 1/29/14 |
Express LD Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Remove the metals content load test used for the monitoring of electropolishing solutions. |
| P090006/S012 1/14/14 |
Complete SE Iliac Vascular Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to the bioburden test method. |
| P090013/S121 1/8/14 |
CAPSUREFIX MRI Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software. |
| P090013/S123 1/16/14 |
CapSureFix MRI Lead, Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products. |
| P090013/S125 1/22/14 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
New supplier for the molding compound used in the manufacturing of capacitors for the hybrid assemblies. |
| P090013/S126 1/16/14 |
CapSureFix MRI Lead, Revo MRI IPG | Medtronic CRDM Mounds View, MN 55112 |
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module. |
| P100021/S031 1/14/14 |
Endurant Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to the bioburden test method. |
| P100026/S007 1/24/14 |
NeuroPace RNS System | NeuroPace, Inc. Mountain View, CA 94043 |
Implement a new database used to collect and store manufacturing test data. |
| P100027/S014 1/22/14 |
INFORM HER2 Dual ISH DNA Probe | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Addition of a new supplier for PCBAs (Printed Circuit Board Assemblies) used in the manufacture of the BenchMark ULTRA Instrument. |
| P100027/S015 1/23/14 |
INFORM HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Addition of a new supplier for a subassembly used in the manufacture of the BenchMark XT Instrument. |
| P100040/S015 1/14/14 |
Valiant Thoracic Stent Graft with the Captivia Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to the bioburden test method. |
| P110011/S006 1/14/14 |
Assurant Cobalt Iliac Balloon-Expandable Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to the bioburden test method. |
| P110013/S032 1/14/14 |
Resolute Integrity Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to the bioburden test method. |
| P110019/S059 1/8/14 |
XIENCE PRIME (XIENCE PRIME and XIENCE PRIME Long Lengths [LL]) on the RX platform | Abbott Vascular Temecula, CA 92590 |
Modifications to the sampling plan for XIENCE final release testing. |
| P110020/S011 1/9/14 |
cobas® 4800 BRAF V600 Mutation Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change to discontinue chemical testing for potassium concentration in master mixes. |
| P110040/S002 1/14/14 |
Complete SE SFA/PPA Vascular Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to the bioburden test method. |
| P110042/S024 1/22/14 |
S-ICD® System | Cameron Health, Inc. San Clemente, CA 92673 |
Additional system used in manufacturing operations for the S-ICD® System. |
| P110042/S025 1/31/14 |
S-ICD System | Cameron Health, Inc. San Clemente, CA 92673 |
Use of a two-part epoxy on the high voltage capacitor used in the S-ICD System. |
