Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 87
Summary of PMA Originals Under Review
Total Under Review: 54
Total Active: 24
Total On Hold: 30
Summary of PMA Supplements Under Review
Total Under Review: 466
Total Active: 340
Total On Hold: 126
Summary of All PMA Submissions
Originals: 3
Supplements: 67
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 87
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 173.2
FDA Time: 127.2 Days
MFR Time: 46.0 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P130024 10/9/14 |
Lutonix 035 Drug Coated Balloon PTA Catheter | Lutonix, Inc. New Hope, MN 55428 |
Approval for the Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB). This device is indicated for percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm. |
| P130026 10/24/14 |
TactiCath Quartz® Catheter and TactiSysQuartz® Equipment | St. Jude Medical St. Paul, MN 55117 |
Approval for the TactiCath Quartz® Catheter and TactiSysQuartz® Equipment. This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P810002/S090 10/7/14 135-Day |
St. Jude Medical Mechanical Heart Valve, SJM Masters Series Mechanical Heart Valve, SJM Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff, SJM Masters Series Mechanical Heart Valve with PTFE Sewing Cuff, SJM Masters Series Mechanical Heart Valve with Expanded PTFE Sewing Cuff, SJM Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff, SJM Masters Series Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff, SJM Masters Series Mechanical Heart Valve with HP Flex Cuff, SJM Regent Heart Valve, SJM Regent Heart Valve with Flex Cuff, SJM Masters Series Aortic Valved Graft with Hemashield Graft Technology, SJM Masters HP Valved Graft with Gelweave Valsalva Technology |
St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for transfer of a component manufacturing process to Caguas, Puerto Rico. |
| P810006/S049 10/31/14 135-Day |
Collastat Absorbable Collagen Hemostatic Sponge | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for a change in cleaning validation process for manufacturing equipment. |
| P810006/S053 10/17/14 135-Day |
CollaStat Absorbable Collagen, Hemostatic Sponge CollaStat, Absorbable Collagen, Hemostatic Agent-Microfibrillar Form |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for the implementation of mechanical, program, and system control changes to the existing Chilled Water System that services collagen lyophilizer machines in the LYO Manufacturing Area of Building 1 at the Integra NeuroSciences facility in Añasco, Puerto Rico for the devices. |
| P840062/S036 10/31/14 135-Day |
CollaCote and CollaTape Absorbable Collagen Wound Dressings for Dental Surgery | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for a change in cleaning validation process for manufacturing equipment. |
| P840062/S040 10/17/14 135-Day |
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for the implementation of mechanical, program, and system control changes to the existing Chilled Water System that services collagen lyophilizer machines in the LYO Manufacturing Area of Building 1 at the Integra NeuroSciences facility in Añasco, Puerto Rico for the devices. |
| P850010/S047 10/31/14 135-Day |
Helistat Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for a change in cleaning validation process for manufacturing equipment. |
| P850010/S053 10/17/14 135-Day |
HeliStat, Helitene Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for the implementation of mechanical, program, and system control changes to the existing Chilled Water System that services collagen lyophilizer machines in the LYO Manufacturing Area of Building 1 at the Integra NeuroSciences facility in Añasco, Puerto Rico for the devices. |
| P850048/S039 10/24/14 Real-Time |
Access Hybritech Total PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the Access Substrate bottle and cap. |
| P860004/S206 10/20/14 180-Day |
SYNCHROMED LIORESAL INFUSION PUMP | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changes to the Model 8835 myPTM used with the Medtronic SynchroMed II Programmable Drug Infusion System. |
| P880086/S247 10/10/14 Real-Time |
Assurity/Endurity Families of Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Approval for minor design modifications to the IS-1 lead bores for the devices. |
| P890064/S031 10/9/14 Real-Time |
Qiagen Digene Hybrid Capture 2 (HC2) HPV DNA Test, Qiagen Digene Hybrid Capture 2 (HC2) High Risk HPV DNA Test | Qiagen Gaithersburg, Inc. Gaithersburg, MD 20878 |
Approval for the upgrade of the HC2 Software Suite to version 4.3. |
| P900033/S035 10/17/14 135-Day |
Integra Dermal Regeneration Template | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for the implementation of mechanical, program, and system control changes to the existing Chilled Water System that services collagen lyophilizer machines in the LYO Manufacturing Area of Building 1 at the Integra NeuroSciences facility in Añasco, Puerto Rico, for the devices. |
| P910001/S072 10/9/14 Real-Time |
Excimer Laser Coronary Atherectomy Catheter | Spectranetics Corporation Colorado Springs, CO 80921 |
Approval for parametric release for the devices. |
| P910023/S344 10/10/14 Real-Time |
Ellipse Family of ICDs | St. Jude Medical Sylmar, CA 91342 |
Approval for minor design modifications to the IS-1 lead bores for the devices. |
| P910062/S007 10/2/14 Real-Time |
STAR Excimer Laser System and WaveScan WaveFront Laser System | AMO Manufacturing USA, LLC Milpitas, CA 95035 |
Approval for redesign of the STAR thyratron trigger board (P/N 0040-0044). |
| P920047/S071 10/17/14 180-Day |
Maestro 3000 Cardiac Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for a manufacturing site located at Stellartech Research Corporation, in Milpitas, California. |
| P930016/S043 10/2/14 Real-Time |
STAR Excimer Laser System and WaveScan WaveFront Laser System | AMO Manufacturing USA, LLC Milpitas, CA 95035 |
Approval for redesign of the STAR thyratron trigger board (P/N 0040-0044). |
| P930039/S107 10/13/14 180-Day |
CapSureFix Novus MRI SureScan Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for adding the 5076 CapSureFix Novus Lead to the MR Conditional pacing family. The device, as modified, will be marketed under the trade name CapSureFix Novus MRI SureScan Model 5076 and is indicated for use as a system consisting of a Medtronic MRI SureScan IPG implanted with SureScan leads. A complete system is required for use in the MRI environment. |
| P950029/S097 10/23/14 Special |
Reply SR, Reply DR, Esprit SR, and Esprit DR Families of Pacemakers | Sorin CRM USA, Inc. Arvada, CO 80004 |
Approval for modifications to the implant manuals in alignment with a previous safety communication. |
| P960009/S203 10/24/14 Real-Time |
ACTIVA IMPLANTABLE NEUROSTIMULATORS | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for a material change to the white DBS boot. |
| P960042/S049 10/9/14 Real-Time |
Spectranetics Laser Sheath Kits | Spectranetics Corporation Colorado Springs, CO 80921 |
Approval for parametric release for the devices. |
| N970003/S167 10/21/14 180-Day |
Ingenio™ Pacemakers (ADVANTIO™, INGENIO™, FORMIO™); Ingenio™ 2 Pacemakers (ALTRUA 2™, ESSENTIO™, PROPONENT™, ACCOLADE™ |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for Ingenio™ Pacemakers (ADVANTIO™ Models K062, K063, K064; INGENIO™ Models K172, K173, K174; VITALIO™ Models K272, K273, K274; FORMIO™ Model K278); Ingenio™ 2 Pacemakers (ALTRUA 2™ Model: S701, S702, S722; ESSENTIO™ Models L100, L101, L121; PROPONENT™ Models L200, L201, L221; ACCOLADE™ Models L300, L301, L321) and Programmer Application Software Model 2869 v2.01. |
| P970004/S172 10/17/14 180-Day |
Medtronic InterStim Therapy for Urinary Control | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changes to the Model 3037 iCon Patient Controller used for Medtronic InterStim Therapy for Urinary Control and Bowel Control. |
| P970038/S028 10/24/14 Real-Time |
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the Access Substrate bottle and cap. |
| P980003/S050 10/17/14 180-Day |
Maestro 3000 Cardiac Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for a manufacturing site located at Stellartech Research Corporation, in Milpitas, California. |
| P980016/S503 10/2/14 Real-Time |
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for a battery design change and associated inspection and production tooling changes. |
| P980022/S156 10/2/14 135-Day |
Paradigm REAL-Time Continuous Glucose Monitoring System, Paradigm REAL-Time Revel Continuous Glucose Monitoring System, Guardian REAL-Time System, MiniLink REAL-Time Continuous Glucose Monitoring System, iPro2 Professional Continuous Glucose Monitoring System |
Medtronic Minimed Northridge, CA 91325 | Approval for a change to replace the current holder (blue test plug) used as a production aid during sub-assembly manufacturing of the MiniLink (MMT-7703) and iPro2 (MMT-7741) transmitters to two new holders. The MiniLink transmitter is a component of the Paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, MiniLink REAL-Time and MiniMed 530G Systems. The iPro2 transmitter is a component of the iPro2 Professional Continuous Glucose Monitoring System. |
| P980022/S160 10/8/14 135-Day |
Paradigm REAL-Time and Paradigm REAL-Time Revel Continuous Glucose Monitoring Systems |
Medtronic Minimed Northridge, CA 91325 |
Approval for a change to a supplier’s production line for a motor part of the Paradigm REAL-Time Insulin Pumps (models MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm REAL-Time Revel Insulin Pumps (models MMT-523, MMT-523K, MMT-723 and MMT-723K) and the MiniMed 530G Insulin Pumps (models MMT-551 and MMT-751). The insulin pumps are components of the Paradigm REAL-Time Continuous Glucose Monitoring System, Paradigm REAL-Time Revel Continuous Glucose Monitoring System, and the MiniMed 530G System respectively. |
| P980041/S029 10/24/14 Real-Time |
Access AFP Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the Access Substrate bottle and cap. |
| P990010/S007 10/2/14 Real-Time |
STAR Excimer Laser System and WaveScan WaveFront Laser System | AMO Manufacturing USA, LLC Milpitas, CA 95035 |
Approval for redesign of the STAR thyratron trigger board (P/N 0040-0044). |
| P990065/S007 10/9/14 Special |
SIR-Spheres® Microspheres | Sirtex Medical Limited North Sydney, AUSTRALIA 2060 |
Approval for an optional use of an alternate non-ionic solution 5% Dextrose (D5W). |
| P000008/S028 10/7/14 180-Day |
LAP-BAND® Adjustable Gastric Banding System | Apollo Endosurgery, Inc. Austin, TX 78746 |
Approval for design changes to the RapidPort EZ Access Port, design changes to the RapidPort EZ Access Port Applier, and packaging changes. |
| P000037/S036 10/28/14 135-Day |
On-X Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78752 |
Approval for vertical integration of a component substrate manufacturing process. |
| P000039/S048 10/29/14 180-Day |
AMPLATZER Septal Occluder (ASO) and Cribiform Occluder (ASD-MF) | AGA Medical Corporation Plymouth, MN 55442 |
Approval for converting the nitinol wire used in the manufacture of these devices from a black oxide surface finish to a chemically etched surface finish. |
| P010013/S058 10/28/14 180-Day |
NovaSure Impedance Controlled Endometrial Ablation Device | Hologic, Inc. Marlborough, MA 01752 |
Approval for device modifications, including flattening of the NVSRAM battery clip and addition of Kapton tape to the NVSRAM battery and the UI Board shield to overcome a device error occurring if contact of these components occurs. |
| P010031/S467 10/2/14 Real-Time |
Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for a battery design change and associated inspection and production tooling changes. |
| P010032/S083 10/15/14 Real-Time |
St. Jude Spinal Cord Stimulation System | St. Jude Medical Plano, TX 75024 |
Approval for minor design changes to the Single 8 Extension (Model 3383) to introduce a new 8-Channel Adapter (Models 2311 and 2316) for Spinal Cord Stimulation (SCS) Systems. The new 8-Channel Adapter is intended to connect a compatible 8- channel Medtronic lead or extension to a St. Jude Medical implantable pulse generator. |
| P020009/S123 10/10/14 135-Day |
Express2® Coronary Stent System (Monorail® & Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a software upgrade to update the radio frequency identification (RFID) reading software. |
| P020024/S038 10/29/14 180-Day |
AMPLATZER Duct Occluder (ADO) | AGA Medical Corporation Plymouth, MN 55442 |
Approval for converting the nitinol wire used in the manufacture of these devices from a black oxide surface finish to a chemically etched surface finish. |
| P020025/S059 10/17/14 180-Day |
Maestro 3000 Cardiac Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for a manufacturing site located at Stellartech Research Corporation, in Milpitas, California. |
| P020026/S086 10/10/14 180-Day |
Cypher Sirolimus-Eluting Coronary Stent | Cordis Corporation Fremont, CA 94555 |
Approval of the post-approval study protocol. |
| P020045/S059 10/1/14 Real-Time |
Freezor Cardiac Cryoablation System | Medtronic CryoCath LP Mounds View, MN 55112 |
Approval to update the leak detection firmware. |
| P020045/S060 10/23/14 Real-Time |
7F FREEZOR CARDIAC CRYOABLATION CATH.& XTRA SURGICAL DEVICE, 9F FREEZOR MAX SURGICAL CATH CATHRYOCONSOLE SYSTEM | Medtronic Cryocath, LP Quebec, Canada H9R 5Z8 |
Approval for a modified check valve in the CryoConsole. |
| P030005/S113 10/21/14 180-Day |
Ingenio™ CRT-P Devices (INVIVE™ CRT-P, INTUA™ CRT-P); Ingenio™ 2 CRT-P Devices (VALITUDE™, VALITUDE™ X4) |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for Ingenio™ CRT-P Devices (INVIVE™ CRT-P Models V172, V173; INTUA™ CRT-P Models V272, V273); Ingenio™ 2 CRT-P Devices (VALITUDE™ Model U125; VALITUDE™ X4 Model U128). |
| P030006/S026 10/24/14 135-Day |
Prolieve Thermodilatation System | Medifocus Incorporated Columbia, MD 21046 |
Approval for replacing the current supplier for manifold tubing, and to replace medical device adhesive currently used in manufacturing. |
| P030017/S203 10/2/14 Special |
Precision ® and Precision SpectraTM Spinal Cord Stimulator (SCS) Systems | Boston Scientific Neuromodulation Valencia, CA 91355 |
Approval for a labeling change to be made to the Precision and Precision Spectra Manuals. The requested change adds supplemental information to the Adverse events section of the manuals in order to provide additional details on the possibility of the formation of reactive tissue around the lead in the epidural space which may result in delayed onset of spinal cord compression and neurological/sensory deficit including paralysis. |
| P030035/S125 10/10/14 Real-Time |
Allure Family of CRT-Ps | St. Jude Medical Sylmar, CA 91342 |
Approval for minor design modifications to the IS-1 lead bores for the devices. |
| P030049/S011 10/28/14 Real-Time |
ADVIA Centaur® HBsAg ReadyPack Reagents, ADVIA Centaur®HBsAg Confirmatory ReadyPack Reagents and ADVIA Centaur®HBsAg Quality Control Material | Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 |
Approval for the addition of two washes of the ancillary probe on the ADVIA Centaur and ADVIA Centaur XP instruments when the ADVIA Centaur HBsAg assay is run immediately following the ADVIA Centaur Syphilis assay. |
| P030050/S017 10/10/14 180-Day |
Sculptra | Galderma Laboratories, L.P. Fort Worth, TX 76177 |
Approval for a change in product labeling to describe the results of a Post Approval Study in patients with HIV associated Lipoatrophy. |
| P030053/S014 10/1/14 180-Day |
MemoryGel Silicone Gel-Filled Breast Implants | Mentor Worldwide, LLC. Santa Barbara, CA 93111 |
Approval of the post-approval study protocol. |
| P040001/S022 10/24/14 180-Day |
X-STOP Interspinous Process Decompression System | Medtronic Sofamor Danek USA, Inc. Memphis, TN 38132 |
Approval of the post-approval study protocol. |
| P040013/S019 10/21/14 135-Day |
GEM 21S | Luitpold Pharmaceuticals Incorporated Norristown, PA 19403 |
Approval for a new filtration step and renovations at the Shirley, New York manufacturing facility. |
| P040040/S022 10/29/14 180-Day |
AMPLATZER VSD Muscular Occluder (VSD-Musc) | AGA Medical Corporation Plymouth, MN 55442 |
Approval for converting the nitinol wire used in the manufacture of these devices from a black oxide surface finish to a chemically etched surface finish. |
| P040043/S067 10/21/14 180-Day |
Gore TAG Thoracic Endoprosthesis | W. L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Approval for an update to the labeling for the Gore TAG Thoracic Endoprosthesis to reflect the findings of the Post-Approval Study. |
| P050023/S078 10/10/14 Real-Time |
Ilesto 7 VR-T, Ilesto 5 VR-T, Ilesto 5 VR-T DX, Iforia 7 VR-T, Iforia 7 VR-T DX, Ilesto 7 DR-T, Ilesto 5 DR-T, Iforia 7 DR-T and Iforia 5 DR-T ICDs; Ilesto 7 HF-T, Iforia 7 HF-T, Ilesto 5 HF-T and Iforia 5 HF-T CRT-Ds |
Biotronik, Inc. 6024 Jean Road Lake Oswego, OR 97035 |
Approval for a Modified Dump Resistor for the Ilesto/Iforia families of ICDs/CRT-Ds. |
| P050034/S013 10/8/14 180-Day |
Implantable Miniature Telescope™ (IMT) Models Wide Angle 2.2X, and Wide Angle 2.7X |
VisionCare Ophthalmic Technologies, Inc. Saratoga, CA 95070 |
Approval to modify the indications for use for the IMT to include patients 65 to 74 years of age from the current minimum of 75 years, to revise the professional and patient labeling to update the data based on the results out to 8-years post IMT implantation, and to revise the acceptance of risk and informed decision agreement, as well as the professional and patient labeling, to emphasize that the longer the IMT is in the eye, the greater the potential risk of developing vision-impairing corneal edema which may lead to the need for corneal transplant and possible telescope removal. The device, as modified, will be marketed under the trade name Implantable Miniature Telescope™ (by Dr. Isaac Lipshitz) (IMT) Models Wide Angle 2.2X and Wide Angle 2.7X and is indicated for monocular implantation to improve vision in patients greater than or equal to 65 years of age with stable severe to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas associated with end-stage age-related macular degeneration. Patients must: 1) have retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography; 2) have evidence of visually significant cataract (> Grade 2); agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision; 3) achieve at least a 5-letter improvement on the ETDRS chart with an external telescope; 3) have adequate peripheral vision in the eye not scheduled for surgery; and 5) agree to participate in postoperative visual training with a low vision specialist. |
| P050037/S050 10/24/14 135-Day |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Approval for changes to the sterilization process for the Radiesse Dermal Filler. |
| P050052/S055 10/24/14 135-Day |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Approval for changes to the sterilization process for the Radiesse Dermal Filler. |
| P060006/S060 10/10/14 135-Day |
Express® SO Renal Monorail® Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a software upgrade to update the radio frequency identification (RFID) reading software. |
| P060033/S092 10/17/14 Real-Time |
Endeavor Sprint Zotarolimus Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval of updates to the Instructions for Use to accurately reflect the correct safety factors for the Zotarolimus drug substance. |
| P070015/S122 10/3/14 Panel-Track |
XIENCE V® and XIENCE nano® Everolimus Eluting Coronary Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Approval for the expansion of the indications for use of the XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System, and XIENCE Alpine Everolimus Eluting Coronary Stent System to include de novo total coronary occlusions.. These devices are indicated for the following: XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System The XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 28mm) with reference vessel diameters of 2.25mm to 4.25mm. Additionally, the XIENCE V stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System. The XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE PRIME stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System The XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE Xpedition stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Alpine Everolimus Eluting Coronary Stent System. The XIENCE Alpine Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE Alpine stent system is indicated for treating de novo chronic total coronary occlusions. |
| P080009/S002 10/7/14 180-Day |
Sedasys Computer-Assisted Personalized Sedation System | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 |
Approval of the post-approval study protocol. |
| P080025/S068 10/17/14 180-Day |
Medtronic InterStim Therapy for Bowel Control | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changes to the Model 3037 iCon Patient Controller used for Medtronic InterStim Therapy for Urinary Control and Bowel Control. |
| P080027/S018 10/2/14 Special |
OraQuick® HCV Rapid Antibody Test | OraSure Technologies, Incorporated Bethlehem, PA 18015 |
Approval for the addition of an in-process inspection as part of the pouching process for the OraQuick® HCV Rapid Antibody Test. |
| P090003/S032 10/10/14 135-Day |
Express® LD Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a software upgrade to update the radio frequency identification (RFID) reading software. |
| P090003/S035 10/10/14 Real-Time |
Express LD Iliac Premounted Stent System | Boston Scientific Maple Grove, MN 55311 |
Approval for modifications to the MRI sections of the product labeling. |
| P090012/S003 10/22/14 180-Day |
MelaFind | Mela Sciences, Inc. Irvington, NY 10533 |
Approval of the post-approval study protocol. |
| P090026/S013 10/24/14 Real-Time |
Access Hybritech P2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the Access Substrate bottle and cap. |
| P100021/S039 10/23/14 Real-Time |
Endurant IIs Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the addition of five (5) short bifurcated stent graft configurations to the Endurant II Stent Graft System, which are called Endurant IIs Stent Grafts (also referred to as Endurant IIs). The device, as modified, will be marketed under the trade name Endurant IIs Stent Graft System. The Endurant II/Endurant IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. The Endurant II aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of bifurcated stent graft. The Endurant II/Endurant IIs stent graft system is indicated for use in patients with the following characteristics: 1) Adequate iliac or femoral access that is compatible with vascular access techniques, devices or accessories; 2) Proximal neck length ≥10 mm; 3) Infrarenal neck angulation ≤60°; 4) Aortic neck diameters with a range of 19 to 32 mm; 5) Distal fixation lengths ≥15 mm; 6) Iliac diameters with a range of 8 to 25 mm; and 7) Morphology suitable for aneurysm repair. |
| P100023/S098 10/10/14 135-Day |
ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a software upgrade to update the radio frequency identification (RFID) reading software. |
| P100028/S004 10/8/14 180-Day |
Formula™ Balloon-Expandable Renal Stent System | Cook Inc. Bloomington, IN 47404 |
Approval for a labeling update based on the post-approval study results. |
| P100046/S005 10/22/14 180-Day |
Atricure Synergy Ablation System | Atricure, Inc. West Chester, OH 45069 |
Approval for a manufacturing site located at Stellartech Research Corporation, Milpitas, California. |
| P100047/S049 10/16/14 180-Day |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Approval for changing the heat seal adhesive coating on the Inner and Outer Trays of the Implant Kit/ Implant Accessories and Surgical Tools. |
| P110010/S085 10/10/14 135-Day |
PROMUS Element Plus™ Everolimus-Eluting Platinum Chromium Coronary Stent System |
Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a software upgrade to update the radio frequency identification (RFID) reading software. |
| P110013/S044 10/16/14 180-Day |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval of the post-approval study protocol. |
| P110019/S066 10/3/14 Panel-Track |
XIENCE PRIMETM® and XIENCE PRIME LLEverolimus Eluting Coronary Stent System, XIENCE Xpedition®, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System and XIENCE AlpineTM Everolimus Eluting Coronary Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Approval for the expansion of the indications for use of the XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System, and XIENCE Alpine Everolimus Eluting Coronary Stent System to include de novo total coronary occlusions.. These devices are indicated for the following: XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System The XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 28mm) with reference vessel diameters of 2.25mm to 4.25mm. Additionally, the XIENCE V stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System. The XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE PRIME stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System The XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE Xpedition stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Alpine Everolimus Eluting Coronary Stent System. The XIENCE Alpine Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE Alpine stent system is indicated for treating de novo chronic total coronary occlusions. |
| P110023/S007 10/10/14 Panel-Track |
EverFlex™ Self-Expanding Peripheral Stent System | ev3, Inc. Plymouth, MN 55441 |
Approval for the EverFlex™ Self-Expanding Peripheral Stent System. This device is indicated for improving luminal diameter in patients with atherosclerotic disease in the common and/or external iliac arteries up to and including 100 mm in length, with a reference vessel diameter of 4.5 – 7.5 mm. |
| P110028/S012 10/3/14 135-Day |
Absolute Pro Vascular Self-Expanding Stent System | Abbott Vascular Santa Clara, CA 95054 |
Approval for a change in the stent expansion process for the Absolute Pro Vascular Self-Expanding Stent System. |
| P120005/S009 10/17/14 180-Day |
Dexcom SHARE System | Dexcom, Inc. San Diego, CA 92121 |
Approval for the Dexcom SHARE System as an optional accessory of the Dexcom G4 PLATINUM Continuous Glucose Monitoring System. The Dexcom SHARE System is manufactured at Leadtek Research Inc. in Taiwan, China. |
| P120005/S018 10/21/14 Panel-Track |
Dexcom G4 PLATINUM Continuous Glucose Monitoring System | DEXCOM, Inc. San Diego, CA 92121 |
Approval for the Dexcom G4 PLATINUM Continuous Glucose Monitoring System. This device is indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription. The Dexcom G4 PLATINUM 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 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 Dexcom G4 PLATINUM System results should be based on the trends and patterns seen with several sequential readings over time. |
| P120005/S026 10/9/14 Real-Time |
Dexcom G4 PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Approval for a new Internet-based Software Update Tool. |
| P120010/S023 10/2/14 135-Day |
MiniMed 530G System | Medtronic Minimed Northridge, CA 91325 | Approval for a change to replace the current holder (blue test plug) used as a production aid during sub-assembly manufacturing of the MiniLink (MMT-7703) and iPro2 (MMT-7741) transmitters to two new holders. The MiniLink transmitter is a component of the Paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, MiniLink REAL-Time and MiniMed 530G Systems. The iPro2 transmitter is a component of the iPro2 Professional Continuous Glucose Monitoring System. |
| P120010/S033 10/8/14 135-Day |
MiniMed 530G System | Medtronic Minimed Northridge, CA 91325 |
Approval for a change to a supplier’s production line for a motor part of the Paradigm REAL-Time Insulin Pumps (models MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm REAL-Time Revel Insulin Pumps (models MMT-523, MMT-523K, MMT-723 and MMT-723K) and the MiniMed 530G Insulin Pumps (models MMT-551 and MMT-751). The insulin pumps are components of the Paradigm REAL-Time Continuous Glucose Monitoring System, Paradigm REAL-Time Revel Continuous Glucose Monitoring System, and the MiniMed 530G System respectively. |
| P120016/S002 10/7/14 Real-Time |
VASCADE™ Vascular Closure System (VCS) | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Approval for the addition of colorant in the push rod component of the VASCADE Vascular Closure System. |
| P120020/S002 10/20/14 180-Day |
IDEV-SUPERA Peripheral Stent System (SFA and Proximal Popliteal) | Abbott Vascular Santa Barbara, CA 95054 |
Approval of the post-approval study protocol. |
| P130004/S001 10/2/14 180-Day |
ReSure Sealant | Ocular Therapeutics, Inc. Bedford, MA 01730 |
Approval of the post-approval study protocol. |
| P130005/S001 10/29/14 Special |
Diamondback 360® Coronary Orbital Atherectomy System | Cardiovascular Systems, Inc. Saint Paul, MN 55112 |
Approval for changes to the Instructions for Use to enhance the safety of the device or use of the device. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N16837/S018 10/2/14 |
Artegraft Collagen Vascular Graft | Artegraft, Inc. North Brunswick, NJ 08902 |
Alternate supplier of a critical process component. |
| N16895/S096 10/2/14 |
Bausch & Lomb® SofLens® (polymacon) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. Rochester, NY 14609 |
Addition of an alternate autoclave for terminally sterilizing SofLens® contact lenses. |
| P810006/S055 10/16/14 |
Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Use of a new quality control test method. |
| P810006/S056 10/22/14 |
Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Use of an updated quality control test method. |
| P810031/S051 10/8/14 |
Sodium Hyaluronate Ophthalmic Visoelastic Devices (OVD), Healon®, Healon GV®, and Healon5® Products, Healon Ultimate Dual Pack and Healon Duet Dual Pack | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Replacement of the quality control sodium chloride test with an osmolality test in the manufacturing of Healon® products. |
| P830055/S149 10/8/14 |
LCS Total Knee System | Depuy Orthopaedics, Inc. Warsaw, IN 46581 |
New ZEISS DURAMAX CMM inspection equipment for the Atture PS RP Inserts |
| P830055/S151 10/10/14 |
LCS Total Knee System | Depuy Orthopaedics, Inc. Warsaw, IN 46581 |
Addition of a 2D barcode and additional scanning steps |
| P830061/S116 10/21/14 |
CapSure Sense Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new Equipment Controller Fixture to communicate the label type and label content. |
| P830061/S117 10/21/14 |
VITATRON EXCELLENCE PS+ LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL. |
| P840001/S282 10/8/14 |
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION | Medtronic, Inc. Minneapolis, MN 55432 |
Implementation an electronic continuous monitoring system in the manufacturing areas. |
| P840001/S283 10/3/14 |
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION | Medtronic, Inc. Minneapolis, MN 55432 |
Add a sterilization system at the Sullivan Lake facility. |
| P840001/S284 10/16/14 |
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION | Medtronic, Inc. Minneapolis, MN 55432 |
Update the software – FACTORY WORKS RELEASE 7.11 used at several manufacturing facilities. |
| P840001/S285 10/16/14 |
RestoreUltra® Neurostimulator, RestoreAdvanced® Neurostimulator, RestoreSensor® Neurostimulator, RestoreUltra® SureScan® MRI Rechargeable Neurostimulator, RestoreAdvanced® SureScan® MRI Rechargeable Neurostimulator, RestoreSensor® SureScan® MRI Rechargeable Neurostimulator |
Medtronic, Inc. Minneapolis, MN 55432 |
Several changes to the inspection methods for the battery and battery subcomponents. |
| P840062/S042 10/16/14 |
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Use of a new quality control test method. |
| P840062/S043 10/22/14 |
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Use of an updated quality control test method. |
| P840064/S057 10/29/14 |
Viscoat® Ophthalmic, Viscosurgical Device, Duovisc® Ophthalmic Viscosurgical Device, Discovisc® Ophthalmic Viscosurgical Device, Provisc® Ophthalmic Viscosurgical Device (latex-free packaging configuration only) | Alcon Laboratories Fort Worth, TX 76134 |
Alternate contract Ethylene Oxide Sterilization vendor for PROVISC®, VISCOAT®, DUOVISC®, and DISCOVISC® Ophthalmic Viscosurgical Devices. |
| P850010/S055 10/16/14 |
Helistat, Helitene Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Use of a new quality control test method. |
| P850010/S056 10/22/14 |
Helistat, Helitene Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Use of an updated quality control test method. |
| P850068/S012 10/17/14 |
Silsoft® (elastofilcon A) Contact Lenses | Bausch & Lomb Rochester, NY 14609 |
Additional autoclave for the Silsoft® (elastofilcon A) contact lenses. |
| P850089/S112 10/21/14 |
CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL. |
| P860004/S212 10/8/14 |
SYNCHROMED INFUSION SYSTEM | Medtronic, Inc. Minneapolis, MN 55432 |
Implementation an electronic continuous monitoring system in the manufacturing areas. |
| P860004/213 10/3/14 |
SYNCHROMED INFUSION SYSTEM | Medtronic, Inc. Minneapolis, MN 55432 |
Add a sterilization system at the Sullivan Lake facility. |
| P860004/S214 10/16/14 |
SYNCHROMED INFUSION SYSTEM | Medtronic, Inc. Minneapolis, MN 55432 |
IMPLENTATION OF THE VARSALA CONT. MONTORING SYS IMPLEMENTATION FOR MANUFACTURING AREAS AT THE SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES |
| P860004/S215 10/17/14 |
SynchroMed Infusion System | Medtronic, Inc. Minneapolis, MN 55432 |
Manufacturing changes to the Anchor Dispenser Tool (ADT) used during the manufacturing process. |
| P860057/S128 10/2/14 |
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral Bioprostheses | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change from porcine to bovine tissue in the post-sterilization testing. |
| P890003/S322 10/21/14 |
VITATRON BRILLIAN S+ VDD LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL. |
| P890003/S323 10/16/14 |
Prodigy IPG | Medtronic, Inc. Mounds View, MN 55112 |
Software update for the Universal Burn-In Test System (UBITS). |
| P890003/S324 10/23/14 |
Prodigy IPG | Medtronic, Inc. Mounds View, MN 55112 |
Reduction in the weld monitoring frequency of the battery. |
| P890047/S044 10/29/14 |
Viscoat® Ophthalmic, Viscosurgical Device, Duovisc® Ophthalmic Viscosurgical Device, Discovisc® Ophthalmic Viscosurgical Device, Provisc® Ophthalmic Viscosurgical Device (latex-free packaging configuration only) | Alcon Laboratories Fort Worth, TX 76134 |
Alternate contract Ethylene Oxide Sterilization vendor for PROVISC®, VISCOAT®, DUOVISC®, and DISCOVISC® Ophthalmic Viscosurgical Devices. |
| P900033/S038 10/16/14 |
Integra Dermal Regeneration Template | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Use of a new quality control test method. |
| P900033/S039 10/22/14 |
Integra Dermal Regeneration Template | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Use of an updated quality control test method. |
| P900033/S040 10/28/14 |
Integra Dermal Regeneration Template | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Qualification of a new shipping container for collagen products. |
| P900061/S132 10/30/14 |
EPICARDIAL PATCH LEAD, ACE Header | Medtronic, Inc Mounds View, MN 55112 |
Replace the manual recording system for monitoring temperature, humidity and analog gauges for monitoring differential pressure with an automated monitoring system. |
| P910023/S345 10/21/14 |
Current DR, Current DR RF, Current Accel DR, Current+ DR, Current VR, Current VR RF, Current Accel VR, Current+ VR, Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR |
St. Jude Medical, Sylmar, CA 91342 |
Alternate supplier for the high voltage (HV) RF Modules utilized in the devices only. |
| P920015/S141 10/2/14 |
TRANSVENOUS, STEROID ELUTING, QUADRIPOLAR, ACTIVE FIXATION, PACE/SENSE VENTRICULAR LEAD-Tunneling Tool |
Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a continuous monitoring system at the Sullivan Lake Manufacturing facility. |
| P920015/S142 10/7/14 |
TRANSVENOUS, STEROID ELUTING, QUADRIPOLAR, ACTIVE FIXATION, PACE/SENSE VENTRICULAR LEAD-Tunneling Tool |
Medtronic CRDM Mounds View, MN 55112 |
Addition of new Ethylene Oxide (EO) Sterilizer System for the device. |
| P920015/S143 10/10/14 |
CapSureFix MRI Lead | Medtronic, Inc. Mounds View, MN 55112 |
Outsource the supply of three molded components used in the manufacture of the lead models. |
| P920015/S144 10/21/14 |
HV SPLITTER/ ADAPTOR KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD |
Medtronic, Inc. Mounds View, MN 55112 |
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL. |
| P920015/S145 10/30/14 |
TRANSVENOUS, STEROID ELUTING, QUADRIPOLAR, ACTIVE FIXATION, PACE/SENSE VENTRICULAR LEAD-Tunneling Tool |
Medtronic, Inc Mounds View, MN 55112 |
Replace the manual recording system for monitoring temperature, humidity and analog gauges for monitoring differential pressure with an automated monitoring system. |
| P920047/S074 10/21/14 |
Blazer II, Blazer II HTD (Blazer II), Blazer Prime HTD | Boston Scientific Corporation San Jose, CA 95134 |
Change to the welding equipment for the handle assembly of the Blazer family of catheters. |
| P930014/S075 10/21/14 |
AcrySof® Intraocular Lenses | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Modified/ shortened curing cycle for use in the manufacturing of AcrySof® Intraocular Lenses. |
| P930039/S119 10/14/14 |
CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, and Vitatron Crystalline Active Fixation Lead | Medtronic, Inc. Mounds View, MN 55112 |
Outsource the supply of three molded components used in the manufacture of the lead models. |
| P930039/S120 10/21/14 |
CapSureFix Novus Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new Equipment Controller Fixture to communicate the label type and label content. |
| P930039/S121 10/21/14 |
SUREFIX LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL. |
| P950005/S053 10/21/14 |
Celsius Electrophysiology Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of a qualified supplier for the extrusion and braiding processes of the catheter in the devices. |
| P950022/S087 10/27/14 |
Durata Family Of High Voltage Leads | St. Jude Medical, Inc. Sunnyvale, CA 94085 |
Add an alternate air stringing process for the cables used in the leads. |
| P950037/S140 10/10/14 |
Selox ST/JT, Setrox S, Dextrus, Tilda JT/T/R, Solox SLX, and Safio S implantable pacemaker lead families | Biotronik, Inc. Lake Oswego, OR 97035 |
Use of supplemental sterilization equipment. |
| P950037/S141 10/21/14 |
Entovis, Evia, Estella, Effecta and Ecuro families of implantable pulse generators, Dextrus, Setrox, Selox, TILDA, P-KIT, Safio and SLX Pacemaker Electrodes, Cardio Messenger LLT Kit | BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Change to the labeling software which is used to print labels for the devices. |
| P960009/S205 10/8/14 |
DBS Accessories, DBS Extensions, DBS Screening Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Implementation an electronic continuous monitoring system in the manufacturing areas. |
| P960009/S206 10/3/14 |
DBS Accessories, DBS Extensions, DBS Screening Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Add a sterilization system at the Sullivan Lake facility. |
| P960009/S207 10/16/14 |
Activa® RC Neurotranstimulator | Medtronic, Inc. Minneapolis, MN 55432 |
Several changes to the inspection methods for the battery and battery subcomponents. |
| P960009/S208 10/16/14 |
DBS Accessories, DBS Extensions, DBS Leads, DBS Neurostimulators Implantable Activa Family, DBS Neurostimulators Implantable Kinetra Family, Neurostimulators Soletra Family, DBS Programming Systems, DBS Recharging Systems, DBS Screening Systems |
Medtronic, Inc. Minneapolis, MN 55432 |
Update the software (use of FACTORY WORKS release 7.11) used at several manufacturing facilities. |
| P960009/S209 10/17/14 |
Deep Brain Stimulation (DBS) INS Activa Family | Medtronic Neurostimulation Minneapolis, MN 55432 |
Changes to the Lead Cap inspection process. |
| P960040/S333 10/16/14 |
DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4, INCEPTA, ENERGEN, and PUNCTUA Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) |
Boston Scientific St. Paul, MN 55112 |
Vertically integrate the manufacture of the spring contacts used in the header components of the devices. |
| P960040/S334 10/20/14 |
DYNAGEN™ ICD, INOGEN™ ICD, ORIGEN™ ICD |
Boston Scientific Corporation St. Paul, MN 55112 |
Manufacture the feedthru rivets of the HV capacitor internally for the devices rather than purchasing from a supplier. |
| P960040/S335 10/28/14 |
DYNAGEN ™ ICD, INOGEN ™ ICD, ORIGEN ™ ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the supplier’s manufacturing process for the backfill hole in the High Voltage Capacitor Cans (HV Cap). |
| P960042/S050 10/30/14 |
Spectranetics Laser Sheath SLS | Spectranetics Corp. Colorado Springs, CO 80921 |
Change in the optical fiber incoming sampling plan. |
| P970004/S183 10/8/14 |
SNS Urinary Accessories, SNS Urinary Extensions, SNS Urinary Screening Trialing Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Implementation an electronic continuous monitoring system in the manufacturing areas. |
| P970004/S184 10/3/14 |
SNS Urinary Accessories, SNS Urinary Extensions, SNS Urinary Screening Trialing Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Add a sterilization system at the Sullivan Lake facility. |
| P970004/S185 10/16/14 |
SNS Urinary Accessories, SNS Urinary Extensions, SNS Urinary Leads, SNS Urinary Neurostimulator Implantable InterStim Family, SNS Urinary Programming Systems, SNS Urinary Screening Trialing Systems (including Temporary Lead) |
Medtronic, Inc. Minneapolis, MN 55432 |
Update the software (FACTORY WORKS release 7.11) used at several manufacturing facilities. |
| P980003/S054 10/28/14 |
Chilli II Cooled Ablation Catheter | Boston Scientific Corp. San Jose, CA 95134 |
Change for a component of the polyurethane adhesive used for Chilli II catheters. |
| P980006/S023 10/15/14 |
PureVision® (balafilcon A) Product Family | Bausch & Lomb Rochester, NY 14609 |
Additional vendor for a raw material (monomer) in the PureVision® (balafilcon A) product family. |
| P980016/S504 10/3/14 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD |
Medtronic, Inc. Mounds View, MN 55112 |
Reduction in the frequency of weld monitoring. |
| P980016/S505 10/16/14 |
EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, and VIRTUOSO II DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
Medtronic, Inc. Mounds View, MN 55112 |
Updates to the distribution center sorter tool system. |
| P980016/S506 10/17/14 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
New press crimp equipment and process for the devices. |
| P980016/S507 10/16/14 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD |
Medtronic, Inc. Mounds View, MN 55112 |
Software update for the Universal Burn-In Test System (UBITS). |
| P980016/S508 10/23/14 |
Maximo II, Protecta, Protecta XT, Secura, and Virtuoso II Families of ICD’s | Medtronic, Inc. Mounds View, MN 55112 |
Reduction in the weld monitoring frequency of the battery. |
| P980023/S061 10/10/14 |
Linoxsmart S/SD/T/TD, Linoxsmart S DX, Vigila, Volta 1CR/1CT/2CR/2CT, Kainox VCS, Protego S/SD/T/TD Implantable Defibrillator Lead Families | Biotronik, Inc. Lake Oswego, OR 97035 |
Use of supplemental sterilization equipment. |
| P980023/S062 10/21/14 |
Kainox VCS, Linoxsmart, D2-KIT, VIGILA, VOLTA and Protego Permanent Defibrillator Electrodes | BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Change to the labeling software which is used to print labels for the devices. |
| P980035/S395 10/16/14 |
ADAPTA, VERSA, SENSIA, ADVISA DR, ADVISA DR MRI, and RELIA IMPLANTABLE PULSE GENERATORS |
Medtronic, Inc. Mounds View, MN 55112 |
Updates to the distribution center sorter tool system. |
| P980035/S396 10/16/14 |
Adapta, Versa, Sensia IPG Advisa DR IPG, Advisa DR MRI IPG, Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Software update for the Universal Burn-In Test System (UBITS). |
| P980035/S397 10/30/14 |
Adapta, Versa, Sensia IPG, Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new hybrid tester platform. |
| P980035/S398 10/23/14 |
Adapta, Versa, and Sensia Families of IPG | Medtronic, Inc. Mounds View, MN 55112 |
Reduction in the weld monitoring frequency of the battery. |
| P980040/S050 10/23/14 |
TECNIS® 1-Piece Lens, TECNIS® Multifocal 1-Piece Lens, SENSAR® 1-Piece IOL, TECNIS® Multifocal 1-Piece Lens and TECNIS® 1-Piece Lens | Abbott Medical Optics Inc. Santa Ana, CA 92705 |
Add a new oil-free compressed air (OFCA) system at the AMO Anasco, Puerto Rico facility. |
| P990025/S041 10/21/14 |
Navistar RMT Electrophysiology Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of a qualified supplier for the extrusion and braiding processes of the catheter in the devices. |
| P990034/S033 10/16/14 |
ISOMED PUMP AND INFUSION SYSTEM | Medtronic, Inc. Minneapolis, MN 55432 |
Update the software (FACTORY WORKS RELEASE 7.11) used at several manufacturing facilities. |
| P990074/S032 10/29/14 |
Natrelle Saline Filled Breast Implants | Allergan Medical Goleta, CA 93117 |
Change in the bioburden testing method and samples used for testing. |
| P990075/S027 10/29/14 |
Mentor SPECTRUM and Saline-Filled Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Change to convert the manual barcode manufacturing process to an automated process to the mandrel used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
| P000009/S059 10/21/14 |
ICS 3000/Renamic Programmers | BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Change to the labeling software which is used to print labels for the devices. |
| P000029/S079 10/10/14 |
Deflux Injectable Gel | Salix Pharmaceuticals, Inc. Raleigh, NC 27615 |
Change the environmental limits of the clean rooms at the firm. |
| P000037/S038 10/10/14 |
On-X Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78752 |
Change to the software used for the Prooftester equipment. |
| P000040/S033 10/21/14 |
Genesys HTA System | Boston Scientific Corporation Marlborough, MA 01752 |
Remove redundant inspections. |
| P010012/S372 10/16/14 |
ORIGEN EL, INOGEN EL, DYNAGEN EL, ORIGEN MINI, INOGEN MINI, DYNAGEN MINI, INCEPTA, ENERGEN, and PUNCTUA Implantable Cardioverter Defibrillators (ICDs) | Boston Scientific St. Paul, MN 55112 |
Vertically integrate the manufacture of the spring contacts used in the header components of the devices. |
| P010012/S373 10/20/14 |
DYNAGEN™, INOGEN™ CRT-D, ORIGEN™ CRT-D |
Boston Scientific Corporation St. Paul, MN 55112 |
Manufacture the feedthru rivets of the HV capacitor internally for the devices rather than purchasing from a supplier. |
| P010012/S374 10/28/14 |
DYNAGEN ™ CRT-D, INOGEN™ CRT-D, ORIGEN™ CRT-D | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the supplier’s manufacturing process for the backfill hole in the High Voltage Capacitor Cans (HV Cap). |
| P010012/S375 10/22/14 |
EASYTRAK 2 LVA Dual Electrode LV-1 Passive, EASYTRAK 2 LVA Dual Electrode IS-1 Passive | Boston Scientific Corporation St. Paul, MN 55112 |
Update the proximal electrode laser welding parameters for welding the proximal electrode to the lead coil. |
| P010013/S060 10/6/14 |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Update on manufacturing procedure to reduce scrap at the work station. |
| P010015/S251 10/16/14 |
CONSULTA, SYNCRA, and VIVA CRT-PACEMAKERS | Medtronic, Inc. Mounds View, MN 55112 |
Updates to the distribution center sorter tool system. |
| P010015/S252 10/21/14 |
ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL. |
| P010015/S253 10/16/14 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
Medtronic, Inc. Mounds View, MN 55112 |
Software update for the Universal Burn-In Test System (UBITS). |
| P010031/S468 10/3/14 |
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Reduction in the frequency of weld monitoring. |
| P010031/S469 10/16/14 |
BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, and VIVA XT CRT-DEFIBRILLATORS |
Medtronic, Inc. Mounds View, MN 55112 |
Updates to the distribution center sorter tool system. |
| P010031/S470 10/17/14 |
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT, Viva S CRT-D, Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
New press crimp equipment and process for the devices. |
| P010031/S471 10/16/14 |
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Software update for the Universal Burn-In Test System (UBITS). |
| P010031/S472 10/23/14 |
Concerto II, Consulta, Maximo II, Protecta, and Protecta XT Families of CRT-D’s | Medtronic, Inc. Mounds View, MN 55112 |
Reduction in the weld monitoring frequency of the battery. |
| P010032/S084 10/6/14 |
Eon Mini Neuromodulation Systems | St. Jude Medical Plano, TX 75024 |
Add manufacturing process changes to the cutting methods, and change in the frequency of lubricant dispensing. |
| P010068/S042 10/21/14 |
Navistar RMT DS Electrophysiology Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of a qualified supplier for the extrusion and braiding processes of the catheter in the devices. |
| P020004/S104 10/16/14 |
Gore Excluder AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Implementing a surface treatment process for the packaging mandrels used in the Gore Excluder AAA Endoprosthesis. |
| P020004/S105 10/17/14 |
GORE® EXCLUDER® AAA Endoprosthesis | W.L. Gore and Flagstaff, AZ 86001 |
Implementation of a new coating on a manufacturing aid mandrel. |
| P020004/S106 10/29/14 |
GORE® EXCLUDER® AAA Endoprosthesis | W.L. Gore and Flagstaff, AZ 86001 |
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing. |
| P020004/S108 10/29/14 |
Excluder AAA Endoprosthesis | W.L. Gore & Flagstaff, AZ 86004 |
Duplicate the sewing capability for catheter component manufacturing from the Flagstaff facility at the Phoenix facility. |
| P020004/S109 10/29/14 |
Excluder AAA Endoprosthesis | W.L. Gore & Flagstaff, AZ 86003 |
Duplicate the stent winding process and new tempering ovens at the Sunnyvale facility. |
| P020009/S126 10/16/14 |
Express2™ Monorail® and OTW Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Change to the carrier tube manufacturing process. |
| P020018/S053 10/21/14 |
Zenith Flex AAA Endovascular Graft, Zenith Renu AAA Ancillary Graft, Zenith Fenestrated AAA Endovascular Graft |
Cook Inc. Bloomington, IN 47402 |
Alternate method to seal the stent graft fabric edges. |
| P020025/S064 10/21/14 |
Blazer II XP (Blazer II XP), Blazer Prime XP | Boston Scientific Corporation San Jose, CA 95134 |
Change to the welding equipment for the handle assembly of the Blazer family of catheters. |
| P020036/S030 10/23/14 |
Cordis® SMART® and SMART® Control® Nitinol Stent Systems | Cordis Corporation Fremont, CA 94555 |
Changes to optimize the pouch sealing process as well as a new pouch sealer. |
| P020045/S062 10/1/14 |
Freezor Cardiac CryoAblation System | Medtronic AF Solutions Mounds View, MN 55112 |
Alternate supplier to Medtronic CryoCath for the electrical cable subassemblies for the Arctic Front Advance/Freezor and the Electrical Umbilical Cable. |
| P020045/S063 10/15/14 |
Freezor Cardiac CryoAblation Catheter, Freezor Xtra Surgical Cardiac CryoAblation Device, Freezor Max Surgical Cardiac CryoAblation Device, |
Medtronic CryoCath Quebec, Canada H9R 5Z8 |
Changes to packaging/labeling systems used to trigger label printing and facilitate selection of product determination for packaging. |
| P020047/S059 10/9/14 |
ML8 Coronary Stent Systems | Abbott Vascular Santa Clara, CA 95054 |
Change to the pyrogen testing process. |
| P020047/S060 10/24/14 |
MULTI-LINK 8 Coronary Stent System | Abbott Vascular Santa Clara, CA 95054 |
Change to the pyrogen testing process. |
| P020049/S004 10/31/14 |
ProCol® Vascular Bioprosthesis | Hancock Jaffe Laboratories, Inc. Irvine, CA 92618 |
Alternate supplier for bovine veins. |
| P020056/S028 10/29/14 |
NATRELLE Silicone-Filled Breast Implants | Allergan Medical Goleta, CA 93117 |
Change in the bioburden testing method and samples used for testing. |
| P030017/204 10/9/14 |
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems | Boston Scientific Corporation Valencia, CA 91355 |
Add a supplier of cables. |
| P030017/S205 10/9/14 |
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems | Boston Scientific Corporation Valencia, CA 91355 |
Add a supplier of printed circuit board components. |
| P030022/S031 10/17/14 |
Reflection Ceramic Acetabular Hip System (RCHS) | Smith & Nephew, Inc. Cordova, TN 38016 |
New vendors. |
| P030031/S061 10/15/14 |
ThermoCool SF (Bi-Directional and Uni-Directional) Catheters |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Modification of the process used to manufacture the ThermoCool SF Irrigated Tip Shell. |
| P030036/S075 10/21/14 |
SELECTSECURE LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL. |
| P030047/S027 10/13/14 |
Cordis® PRECISE® Nitinol Stent System | Cordis Corporation Fremont, CA 94555 |
Changes to optimize the pouch sealing process as well as a new pouch sealer. |
| P030053/S020 10/29/14 |
Mentor MEMORYGEL Silicone Gel-Filled Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Change to convert the manual barcode manufacturing process to an automated process to the mandrel used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
| P030054/S275 10/21/14 |
Promote, Promote Accel, Promote RF, Promote Q, Promote Quadra, Promote+, Quadra Assura, Unify, Unify Assura, Unify Quadra | St. Jude Medical, Sylmar, CA 91342 |
Alternate supplier for the high voltage (HV) RF Modules utilized in the devices only. |
| P040016/S132 10/16/14 |
VeriFLEX™ (Liberté®) Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Change to the carrier tube manufacturing process. |
| P040027/S038 10/29/14 |
GORE® VIATORR® TIPS Endoprosthesis | W.L. Gore and Flagstaff, AZ 86001 |
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing. |
| P040037/S071 10/17/14 |
GORE® VIABAHN® Endoprosthesis | W.L. Gore and Flagstaff, AZ 86001 |
Implementation of a new coating on a manufacturing aid mandrel. |
| P040037/S072 10/24/14 |
GORE® VIABAHN® Endoprosthesis | W.L. Gore and Associates, Inc. Flagstaff, AZ 86001 |
Implementation of an alternate PTFE resin raw material. |
| P040037/S073 10/29/14 |
GORE® VIABAHN® Endoprosthesis | W.L. Gore and Flagstaff, AZ 86001 |
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing. |
| P040043/S068 10/17/14 |
GORE® TAG® Thoracic Endoprosthesis | W.L. Gore and Flagstaff, AZ 86001 |
Implementation of a new coating on a manufacturing aid mandrel. |
| P040043/S069 10/29/14 |
GORE® TAG® Thoracic Endoprosthesis | W.L. Gore and Flagstaff, AZ 86001 |
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing. |
| P040046/S011 10/29/14 |
NATRELLE Highly Cohesive Silicone-Filled Breast Implants | Allergan Medical Goleta, CA 93117 |
Change in the bioburden testing method and samples used for testing. |
| P050006/S043 10/29/14 |
GORE® HELEX® Septal Occluder | W.L. Gore and Flagstaff, AZ 86001 |
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing. |
| P050007/S032 10/10/14 |
StarClose SE Vascular Closure System | Abbott Vascular, Inc. Temecula, CA 92590 |
Modified cleaning process for the clip subassembly. |
| P050023/S080 10/21/14 |
Ilesto, Iforia and Lumax Families of ICDs and CRT-Ds | BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Change to the labeling software which is used to print labels for the devices. |
| P050042/S030 10/16/14 |
ARCHITECT Anti-HCV | Abbott Laboratories Abbott Park, IL 60064 | Addition of an alternate supplier for a material used in the manufacture of upstream assay components. |
| P050051/S027 10/29/14 |
ARCHITECT AUSAB | Abbott Laboratories Abbott Park, IL 60064 |
Addition of an alternate supplier for a raw material used in the manufacture of the ARCHITECT AUSAB reagent kit. |
| P060010/S012 10/6/14 |
Spanner Temporary Prostatic Stent | SRS Medical Systems, Inc. North Billerica, MA 01862 |
Utilization of a larger existing cleanroom within the current manufacturing facility. |
| P060028/S002 10/29/14 |
MEMORYSHAPE Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Change to convert the manual barcode manufacturing process to an automated process to the mandrel used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
| P060035/S023 10/16/14 |
ARCHITECT CORE-M | Abbott Laboratories Abbott Park, IL 60064 | Addition of an alternate supplier for a material used in the manufacture of upstream assay components. |
| P060039/S064 10/21/14 |
ATTAIN STARFIX LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL. |
| P070008/S055 10/10/14 |
Corox OTW/OTW-S/OTW-L and Celerity 2D/3D/ Pilot Left Ventricular Lead Families |
Biotronik, Inc. Lake Oswego, OR 97035 |
Use of supplemental sterilization equipment. |
| P070008/S056 10/21/14 |
Evia, Entovis and Stratos Families of CRT-Ps. Corox OTW and CELERITY Families of Pacemaker Electrodes, LV-KIT | BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Change to the labeling software which is used to print labels for the devices. |
| P070015/S124 10/9/14 |
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent Systems |
Abbott Vascular Santa Clara, CA 95054 |
Change to the pyrogen testing process. |
| P070015/S125 10/22/14 |
XIENCE Prime® Everolimus Eluting Coronary Stent Systems, XIENCE Xpedition® Everolimus Eluting Coronary Stent Systems, XIENCE Alpine® Everolimus Eluting Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Change to the timing of sampling for particulate testing for product release testing. |
| P070015/S126 10/24/14 |
XIENCE Prime® Everolimus Eluting Coronary Stent Systems, XIENCE Xpedition® Everolimus Eluting Coronary Stent Systems, XIENCE Alpine® Everolimus Eluting Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Change to the pyrogen testing process. |
| P080006/S074 10/2/14 |
Attain Performa Quadripolar Lead | Medtronic, Inc Mounds View, MN 55112 |
Updating the final packaging line at the Villalba, Puerto Rico facility. |
| P080006/S075 10/30/14 |
Attain Performa Quadripolar Lead | Medtronic, Inc Mounds View, MN 55112 |
Replace the manual recording system for monitoring temperature, humidity and analog gauges for monitoring differential pressure with an automated monitoring system. |
| P080020/S013 10/30/14 |
Gel-One | Seikagaku Corporation Tokyo Japan 100-0005 |
Continuation of shared manufacturing equipment for additional purposes. |
| P080023/S025 10/16/14 |
ARCHITECT CORE | Abbott Laboratories Abbott Park, IL 60064 | Addition of an alternate supplier for a material used in the manufacture of upstream assay components. |
| P080025/S079 10/8/14 |
SNS Bowel Accessories, SNS Bowel Extensions, SNS Bowel Screening Trialing Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Implementation an electronic continuous monitoring system in the manufacturing areas. |
| P080025/S080 10/3/14 |
SNS Bowel Accessories, SNS Bowel Extensions, SNS Bowel Screening Trialing Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Add a sterilization system at the Sullivan Lake facility. |
| P080025/S081 10/16/14 |
SNS Bowel Accessories, SNS Bowel Extensions, SNS Bowel Leads, SNS Bowel Neurostimulators Implantable InterStim Family, SNS Bowel Programming Systems, SNS Bowel Screening Trialing Systems (including Temporary Leads) |
Medtronic, Inc. Minneapolis, MN 55432 |
Update the software (FACTORY WORKS RELEASE 7.11)used at several manufacturing facilities. |
| P090013/S157 10/10/14 |
Sprint Quattro Lead | Medtronic, Inc. Mounds View, MN 55112 |
Outsource the supply of three molded components used in the manufacture of the lead models. |
| P090013/S158 10/16/14 |
REVO MRI IMPLANTABLE PULSE GENERATORS | Medtronic, Inc. Mounds View, MN 55112 |
Updates to the distribution center sorter tool system. |
| P090013/S159 10/21/14 |
CapSureFix MRI Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new Equipment Controller Fixture to communicate the label type and label content. |
| P090013/S160 10/21/14 |
CAPSUREFIX MRI LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL. |
| P090013/S161 10/16/14 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Software update for the Universal Burn-In Test System (UBITS). |
| P100010/S044 10/1/14 |
Arctic Front CryoCatheter System | Medtronic AF Solutions Mounds View, MN 55112 |
Alternate supplier to Medtronic CryoCath for the electrical cable subassemblies for the Arctic Front Advance/Freezor and the Electrical Umbilical Cable. |
| P100010/S045 10/15/14 |
Freezor Max Cardiac CryoAblation Device, Arctic Front Cardiac Cryoablation Catheter, Arctic Front Advance Cardiac Cryoablation Catheter |
Medtronic CryoCath Quebec, Canada H9R 5Z8 |
Changes to packaging/labeling systems used to trigger label printing and facilitate selection of product determination for packaging. |
| P100014/S016 10/10/14 |
Solesta | Salix Pharmaceuticals, Inc. Raleigh, NC 27615 |
Changes to the environmental limits of the clean rooms used during Solesta manufacturing. |
| P100021/S040 10/3/14 |
Endurant & Endurant II Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Addition of an alternate supplier for the secondary and tertiary packaging for Endurant and Endurant II Stent Graft Systems. Additionally, a change in configuration for the E-beam sterilization process. |
| P100023/S107 10/22/14 |
Ion™ Paclitaxel-eluting Platinum Chromium Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Implement an update to software on the Automated Catheter Manufacturing Line. |
| P100023/S108 10/30/14 |
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of a redundant in-process stent mass measurement step at the Galway and Plymouth manufacturing sites. |
| P100041/S058 10/2/14 |
SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change from porcine to bovine tissue in the post-sterilization testing. |
| P100041/S059 10/20/14 |
SAPIEN® Transcatheter Heart Valve (TVH) | Edwards Lifesciences LLC Irvine, CA 92614 |
Implementation of an additional OD inspection to the SAPIEN® and SAPIEN XT™ Transcatheter Heart Valves, Models 9000TFX and 9300TFX. |
| P100047/S050 10/10/14 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Changes to the Process Challenge Device (PCD) used for monitoring the Ethylene Oxide sterilization cycle of the sterilized components. |
| P110010/S094 10/22/14 |
PROMUS Element™ Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Implement an update to software on the Automated Catheter Manufacturing Line. |
| P110010/S097 10/30/14 |
PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of a redundant in-process stent mass measurement step at the Galway and Plymouth manufacturing sites. |
| P110013/S045 10/8/14 |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Modification to the residual solvents quality control test method. |
| P110014/S004 10/22/14 |
MarginProbe System | Dune Medical, Ltd. Caesarea Industrial Park Israel 38900 |
Addition of a test jig and the replacement of the vacuum pressure regulator component. |
| P110019/S071 10/9/14 |
XIENCE PRIME and XIENCE PRIME LL Everolimus- Eluting Coronary Stent Systems and Xience Xpedition Everolimus-Eluting Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Change to the pyrogen testing process. |
| P110019/S072 10/22/14 |
XIENCE V® Everolimus Eluting Coronary Stent Systems, XIENCE nano® Everolimus Eluting Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Change to the timing of sampling for particulate testing for product release testing. |
| P1100019/S073 10/24/14 |
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems, XIENCE Xpedition Everolimus Eluting Coronary Stent Systems and XIENCE Alpine Everolimus Eluting Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Change to the pyrogen testing process. |
| P110021/S044 10/2/14 |
SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change from porcine to bovine tissue in the post-sterilization testing. |
| P110021/S045 10/20/14 |
SAPIEN® Transcatheter Heart Valve (TVH) | Edwards Lifesciences LLC Irvine, CA 92614 |
Implementation of an additional OD inspection to the SAPIEN® and SAPIEN XT™ Transcatheter Heart Valves, Models 9000TFX and 9300TFX. |
| P110021/S046 10/23/14 |
SAPIEN™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Changes to the sampling plan for product verification testing of the delivery systems and accessories manufactured at the Irvine, California facility. |
| P110032/S009 10/28/14 |
Aorfix AAA Stent Graft System | Lombard Medical Technologies, Inc. Irvine, CA 92618 |
Use of a new cleanroom at an existing manufacturing site. |
| P110042/S041 10/23/14 |
S-ICD System | Boston Scientific Corporation St. Paul, MN 55112 |
Modification to the test software for the S-ICD at E2 and E4 electrical test steps. |
| P110043/S008 10/9/14 |
Omnilink Elite Vascular Balloon-Expandable Stent System | Abbott Vascular Santa Clara, CA 95054 |
Change to the pyrogen testing process. |
| P120002/S005 10/23/14 |
Cordis® SMART® and SMART® Control® Vascular Stent Systems | Cordis Corporation Fremont, CA 94555 |
Changes to optimize the pouch sealing process as well as a new pouch sealer. |
| P120010/S034 10/2/14 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
New laser system be added to the sensor fabrication process for the Enlite Sensor (MMT-7708), a component of the MiniMed 530G System. |
| P120010/S035 10/2/14 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Modification of drawing specifications for the Sensor Patch used with the Enlite Sensor (MMT-7008) and the addition of another inspection measurement. The Enlite Sensor is a component of the MiniMed 530G System. |
| P120016/S006 10/23/14 |
Cardiva Medical VASCADE™ Vascular Closure System (VCS) | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Reorganization of two existing manufacturing steps and a change of location of the processes to be performed to outside of a Controlled Environment Room (CER). |
| P130004/S005 10/10/14 |
RESURE® SEALANT | Ocular Therapeutix, Inc. Bedford, MA 01730 |
Critical Supplier Location Change- Additional Facility for JenKem, Technology. |
| P130006/S011 10/17/14 |
GORE® VIABAHN® Endoprosthesis | W.L. Gore and Flagstaff, AZ 86001 |
Implementation of a new coating on a manufacturing aid mandrel. |
| P130006/S012 10/24/14 |
GORE® VIABAHN® Endoprosthesis | W.L. Gore and Associates, Inc. Flagstaff, AZ 86005 |
Implementation of an alternate PTFE resin raw material. |
| P130006/S013 10/29/14 |
GORE® VIABAHN® Endoprosthesis | W.L. Gore and Flagstaff, AZ 86001 |
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing. |
| P130009/S011 10/2/14 |
SAPIEN XT™ Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change from porcine to bovine tissue in the post-sterilization testing. |
| P130009/S012 10/20/14 |
Edwards SAPIEN XT™ Transcatheter Heart Valve (TVH) | Edwards Lifesciences LLC Irvine, CA 92614 |
Implementation of an additional OD inspection to the SAPIEN® and SAPIEN XT™ Transcatheter Heart Valves, Models 9000TFX and 9300TFX. |
| P130009/S013 10/23/14 |
SAPIEN XT™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Changes to the sampling plan for product verification testing of the delivery systems and accessories manufactured at the Irvine, California facility. |
| P130009/S014 10/24/14 |
SAPIEN XT™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Change to the testing requirements for the crimp and expansion test for the valve frames. |
| P130021/S007 10/10/14 |
Medtronic CoreValve System | Medtronic CoreValve, LLC Santa Rosa, CA 95403 |
Expand the capacity of the clean room used to perform the tissue processing steps for the CoreValve Transcatheter Aortic Valve at the Medtronic Mexico facility. |
| P130030/S004 10/21/14 |
REBEL Platinum Chromium Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Eliminate burst, diameter, and distension in-process monitoring requirements from the balloon component manufacturing process. |
| P130030/S005 10/22/14 |
REBEL™ Platinum Chromium Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Implement an update to software on the Automated Catheter Manufacturing Line. |
| P130030/S006 10/30/14 |
Rebel Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of a redundant in-process stent mass measurement step at the Galway and Plymouth manufacturing sites. |
