Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 62
Summary of PMA Originals Under Review
Total Under Review: 62
Total Active: 29
Total On Hold: 33
Summary of PMA Supplements Under Review
Total Under Review: 556
Total Active: 430
Total On Hold: 126
Summary of All PMA Submissions
Originals: 4
Supplements: 78
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 62
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 148.0
FDA Time: 116 Days
MFR Time: 32.0 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P130023 2/3/15 |
TissuGlu® Surgical Adhesive | Cohera Medical, Incorporated Pittsburg, PA 15212 |
Approval for the TissuGlu® Surgical Adhesive. This device is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty. |
P140018 2/20/15 |
VenaSeal Closure System | Covidien, LLC Morrisville, NC 27560 |
Approval for the VenaSeal Closure System. This device is indicated for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. VenaSeal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS). |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P850064/S027 2/13/15 180-Day |
Life Pulse® High Frequency Ventilator | Bunnell, Inc. Salt Lake City, UT 84115 |
Approval for a new patient box for the device. |
P860003/S077 2/3/15 Real-Time |
THERAKOS® UVAR XTS® Photopheresis System Procedural Kits | Therakos, Inc. Bridgewater, NJ 08807 |
Approval for a change in the polypropylene material used for the effluent tube of the centrifuge bowls in the UVAR XTS® Photopheresis System Procedural Kits. |
P860004/S205 2/25/15 Real-Time |
Synchromed II Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for Synchromed II Infusion System refill kit model 8555 and IsoMed Infusion System refill kit models 8555 and 8553. |
P880006/S092 2/15/15 Real-Time |
SENSOLOG/ DIALOG/ REGENCY FAMILY OF PACEMAKERS |
St. Jude Medical, Inc. Sunnyvale, CA 94085 |
Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer. |
P880086/S253 2/25/15 Real-Time |
AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS |
St. Jude Medical, Inc. Sunnyvale, CA 94085 |
Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer. |
P900033/S026 2/5/15 135-Day |
INTEGRA Dermal Regeneration Template | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for the following changes: 1) Change in cleaning detergent for certain equipment; 2) Change in cleaning method for certain equipment, utilizing isopropyl alcohol; 3) Establishment of equipment Dirty Hold Time (DHT); and 4) Establishment of a method to test for residues. |
P900033/S041 2/12/14 135-Day |
Integra Dermal Regeneration Template | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for changes to the bioburden testing protocol for the Integra Dermal Regeneration Template. |
P910023/S352 2/25/15 Real-Time |
ELLIPSE/FORTIFY ASSURA FAMILY OF ICDs | St. Jude Medical, Inc. Sunnyvale, CA 94085 |
Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer. |
P930014/S077 2/17/15 180-Day |
Acrysof® Toric IOL & Acrysof® IQ Toric IOL | Alcon Research, Ltd. Ft. Worth, TX 76134 |
Approval of the following changes to the post-approval study for the device: Update the targeted number of subjects to be implanted from 415 to 400. |
P930029/S049 2/12/15 Real-Time |
ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS. | Medtronic, Inc. Mounds View, MN 55112 |
Approval for design changes for cables and foot switches required to meet RoHS compliance. |
P950037/S139 2/10/15 180-Day |
Dromos DR/SR rate Adaptive Pacing System | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Inventra, Iperia and Itrevia ICD and CRT-D devices as well as updates to non-implanted components Renamic, PSW 1401.U and the Home Monitoring Service Center to support the introduction of the new ICD and CRT-D devices. |
P960016/S051 2/2/15 Real-Time |
Livewire TC Ablation Catheter Safire Bi-Directional Ablation Catheter |
St. Jude Medical St. Paul, MN 55117 |
Approval for a change to the buckle force product requirement for the Livewire TC and Safire Bi-Directional Ablation Catheters. |
N970003/S170 2/25/15 Real-Time |
Ingenio 2 Pacemakers: Accolade, Proponent, Essentio, Altura 2; Ingenio Pacemakers: Formio, Vitalio, Ingenio, Advantio | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for a programming application software change for selected pacemakers and cardiac resynchronization therapy-pacemakers. |
P970013/S063 2/25/15 Real-Time |
MICRONY Family of Pacemakers | St. Jude Medical, Inc. Sunnyvale, CA 94085 |
Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer. |
P980022/S161 2/13/15 Real-Time |
Paradigm Real-Time System, Paradigm Real-Time Revel System |
Medtronic MiniMed Northridge, CA 91325 |
Approval for changes to the pump motor sintered bearing material. |
P980043/S048 2/25/15 180-Day |
Hancock II Porcine Bioprosthesis Heart Valve | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for a change to stent material from acetal homopolymer (AHP) to polyetheretherketone, PEEK i5R (PEEK) for the devices. |
P990009/S039 2/26/15 |
Floseal Hemostatic Matrix | Baxter Healthcare Corporation. Round Lake, IL 60073 |
Approval for a manufacturing site located at Baxter Healthcare Corporation in Cleveland, Missouri. |
P990034/S031 2/25/15 Real-Time |
IsoMed Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for Synchromed II Infusion System refill kit model 8555 and IsoMed Infusion System refill kit models 8555 and 8553. |
P990064/S057 2/25/14 180-Day |
Mosaic Porcine Bioprosthesis Heart Valve | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for a change to the stent material from acetal homopolymer (AHP) to polyetherether- ketone, PEEK i5R (PEEK) for the devices. |
P990074/S029 2/11/15 180-Day |
NATRELLE Saline-Filled Breast Implants | Allergan Irvine, CA 92612 |
Approval for a manufacturing site located at Pro-Tech Design and Manufacturing, Inc., in Arlington, Texas. |
P990081/S030 2/19/15 135-Day |
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for the addition of Sanmina built Nozzle Plate Assembly in the manufacture of BenchMark XT instrument used in the tests. |
P000006/S044 2/23/15 Special |
Titan Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Approval to implement an additional in-process test during the manufacturing of the Titan Touch pump. |
P000037/S037 2/9/15 180-Day |
On-X Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78752 |
Approval for modified device packaging and an extension to the product shelf life. |
P010030/S058 2/22/15 Real-Time |
LifeVest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Approval for 1) Adding a new section to the Patient Manual that addresses Environmental Considerations Related to Noise and Vibration; 2) Adding a new section to the Operator Manual that addresses Physician Information To Instruct Patient Caregivers; and 3) Adding a new section to the Patient Manual that addresses What Family Members Need to Know. |
P010032/S087 2/12/15 Real-Time |
St. Jude Spinal Cord Stimulation System/8-Channel Adaptor | St. Jude Medical Plano, TX 75024 |
Approval for minor labeling changes to the SJM 8-channel adaptor (models 2311 and 2316); specifically, to include the use of the adaptor with the SJM trial system. |
P010047/S036 2/13/15 Panel-Track |
ProgelTM Pleural Air Leak Sealant | Neomend, Inc. Irvine, CA 92618 |
Approval for the Progel Pleural Air Leak Sealant (PALS). The single use Progel Pleural Air Leak Sealant device is indicated for application to visceral pleura after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks incurred during resection of lung parenchyma. |
P020055/S015 2/19/15 135-Day |
PATHWAY Anti-C-KIT (9.7) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for the addition of Sanmina built Nozzle Plate Assembly in the manufacture of BenchMark XT instrument used in the tests. |
P020056/S025 2/11/15 180-Day |
NATRELLE Silicone-Filled Breast Implants | Allergan Irvine, CA 92612 |
Approval for a manufacturing site located at Pro-Tech Design and Manufacturing, Inc., in Arlington, Texas. |
P020056/S026 2/25/15 180-Day |
Natrelle Silicone-filled Breast Implants | Allergan Irvine, CA 92612 |
Approval for a line extension identified as the Natrelle Inspira Silicone-Filled Breast Implants to add breast implant options to the Natrelle Silicone-filled Breast Implants. |
P030005/S116 2/25/15 Real-Time |
Ingenio 2 CRT-Ps: Valitude, Valitude X4 Ingenio CRT-Ps: Intua, Invive | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for a programming application software change for selected pacemakers and cardiac resynchronization therapy-pacemakers. |
P030011/S030 2/12/15 Real-Time |
SynCardia Temporary Total Artificial Heart | SynCardia Systems, Inc. Tucson, AZ 85713 |
Approval for a minor design change to the Freedom Driver AC Power Supply. |
P030017/S209 2/12/15 Real-Time |
CoverEdge 32 Surgical Leads/Precision Spectra™ MR Conditional SCS System | Boston Scientific Neuromodulation Valencia, CA 91355 |
Approval for minor labeling changes to the Precision Spectra™ MR Conditional Spinal Cord Stimulation System; specifically, the addition of the CoverEdge 32 Surgical Leads (SC-8336-50 and SC-8352-50) to the system. |
P030017/S210 2/13/15 180-Day |
Precision Spinal Cord Stimulator (SCS) System and Precision Spectra Spinal Cord Stimulator (SCS) System | Boston Scientific Corp. Valencia, CA 91355 |
Approval for the Precisio S8 Adapter that will be used to connect the Precision Implantable Pulse Generator (IPG) or the Precision Spectra IPG to the following St. Jude Medical (SJM) SCS Leads: 3283/3286/3268/ 3269 Lamitrode S8, 3280 Lamitrode 8, 3244/3262/3263 Lamitrode 44, 3245/3264/3265 Lamitrode 44C, 3208 Lamitrode Tripole 8, 3210 Lamitrode Tripole 8C, 3288 Lamitrode 88, 3289 Lamitrode 88C, 3214 Lamitrode Tripole 16C, 3219 Lamitrode Tripole 16, 3228 Penta, 3183/3186/3189/3191 Octrode, 3086 Octrode Trial Lead Kit, 2283 8-channel Adapter, 3341/ 3342/ 3343/3346 Dual 4 Extension, 3382/3383/3386 Single 8 Extension. |
P030035/S131 2/25/15 Real-Time |
FRONTIER/ FRONTIER II/ ANTHEM FAMILY OF CRT-Ps |
St. Jude Medical, Inc. Sunnyvale, CA 94085 |
Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer. |
P030054/S281 2/25/15 Real-Time |
QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-Ds; MERLIN PATIENT CARE SYSTEM PROGRAMMER |
St. Jude Medical, Inc. Sunnyvale, CA 94085 |
Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer. |
P040004/S010 2/27/15 180-Day |
ADVIA Centaur® HBc Total ReadyPack Reagents, ADVIA Centaur® HBc Total Quality Control Materials | Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 |
Approval for claims to test neonate and pediatric populations with the FDA approved ADVIA Centaur HBc Total ReadyPack Reagents and ADVIA Centaur HBc Total Quality Control Materials. The device, as modified, will be marketed under the trade name ADVIA Centaur HBc Total ReadyPack Reagents and ADVIA Centaur HBc Total Quality Control Materials and is indicated for: ADVIA Centaur and ADVIA Centaur XP systems: The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human neonatal, pediatric and adult serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP systems. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. ADVIA Centaur CP System: The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human neonatal, pediatric, and adult serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur CP system. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. |
P040046/S007 2/11/15 180-Day |
NATRELLE Highly Cohesive Silicone-Filled Breast Implants | Allergan Irvine, CA 92612 |
Approval for a manufacturing site located at Pro-Tech Design and Manufacturing, Inc., in Arlington, Texas. |
P050023/S079 2/10/15 180-Day |
Inventra 7 VR-T, Iperia 7 VR-T, Itrevia 7 VR-T, Iperia 5 VR-T, Itrevia 5 VR-T, Inventra 7 VR-T DX, Iperia 7 VR-T DX, Itrevia 7 VR-T DX, Iperia 5 VR-T DX and Itrevia 5 VR-T DX ICD Devices; Inventra 7 DR-T, Iperia 7 DR-T, Itrevia 7 DR-T, Iperia 5 DR-T and Itrevia 5 DR-T ICD Devices; Inventra 7 HF-T, Iperia 7 HF-T, Itrevia 7 HF-T, Iperia 5 HF-T and Itrevia 5 HF-T CRT-D Devices |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Inventra, Iperia and Itrevia ICD and CRT-D devices as well as updates to non-implanted components Renamic, PSW 1401.U and the Home Monitoring Service Center to support the introduction of the new ICD and CRT-D devices. |
P060022/S020 2/3/15 Real-Time |
Akreos AO60 Intraocular Lens (IOL) | Bausch + Lomb Surgical Irvine, CA 92618 |
Approval to modify the labeling to include the Bausch + Lomb IOL Injector (Model VIS100) to the validated inserters list on the labeling of the Akreos AO60 Intraocular Lens (IOL). |
P060040/S038 2/12/15 Special |
Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Thoratec Corp. Pleasanton, CA 94588 |
Approval for implementation of an additional existing Electrical Continuity test during the manufacturing process of the HeartMate II Left Ventricular Assist System (LVAS). |
P080012/S021 2/10/15 180-Day |
Prometra Programmable Infusion Pump System | Flowonix Medical, Inc. Mt. Olive, NJ 07828 |
Approval for a new programmer device. The device, as modified, will be marketed under the trade name Prometra Programmable Infusion Pump System and is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP). |
P080012/S024 2/12/15 Real-Time |
Prometra Programmable Infusion Pump System | Flowonix Medical, Incorporated Mt. Olive, NJ 07828 |
Approval for implementing a mixed load sterilization configuration for the Prometra Pumps accessory kits, which are ethylene oxide sterilized. |
P090015/S002 2/13/15 Real-Time |
BOND Oracle HER2 IHC System | Leica Biosystems, Newcastle Ltd Newcastle upon Tyne, United Kingdom NE12 8EW |
Approval for introduction of BOND version 5.1 software for use on the BOND Oracle HER2 IHC System. |
P090031/S003 2/4/15 Real-Time |
Monovisc | Anika Therapeutics, Incorporated Bedford, MA 01730 |
Approval to expand the specification for residual methanol in Monovisc from < 0.05% to < 0.03% w/w to be in accordance with residual solvent testing limits under USP General Chapter <467>, to revise the stability testing protocol for Monovisc, and to extend the shelf life of Monovisc from 2 years to 3 years utilizing this revised stability testing protocol. |
P100010/S046 2/27/15 180-Day |
Arctic Front Advance ST Cardiac Cryoablation Catheter | Medtronic Cryocath LP Quebec, Canada H9R5Z8 |
Approval for two new models to be added to the Arctic Front family of Cardiac CryoAblation Catheters: Arctic Front Advance ST Cardiac CryoAblation Catheters Models 2AFAST23 and 2AFAST28. |
P100014/S013 2/12/15 135-Day |
Solesta | Salix Pharmaceuticals, Inc. Raleigh, NC 27615 |
Approval for an extension of the clean room used during the manufacture of Solesta. |
P100025/S007 2/3/15 180-Day |
BreathTek® UBT for H. pylori and pUHR-CA | Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 |
Approval for Cambridge Isotope Laboratories, Inc. (CIL’s) amended Drug Master File (DMF) #11378 on behalf of OAPI’s PMA Application which uses the drug as a component of the BreathTek UBT for H. pylori Kit. This supplement requests the review of the following changes to the Drug Master File: 1. Process change to manufacturing scale to add 18kg process; 2. Update to specifications and test methods for 13C-Urea; 3. Changes in QC testing locations; and 4. Changes in manufacturing locations for 18kg process. |
P100027/S019 2/19/15 135-Day |
INFORM HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for the addition of Sanmina built Nozzle Plate Assembly in the manufacture of BenchMark XT instrument used in the tests. |
P100046/S006 2/12/15 Real-Time |
AtriCure Synergy Ablation System | Atricure, Inc. West Chester, OH 45069 |
Approval for updating the transformer in the ASU Generator. |
P110002/S009 2/5/15 Real-Time |
Mobi-C® Cervical Disc Prosthesis | LDR Spine USA Austin, TX 78750 |
Approval for modifications made to the Mobi-C Universal Inserter instrument, which included addition of material to increase the inner diameter and a change to the laser marking and passivation process. |
P110009/S009 2/5/15 Real-Time |
Mobi-C® Cervical Disc Prosthesis | LDR Spine USA Austin, TX 78750 |
Approval for modifications made to the Mobi-C Universal Inserter instrument, which included addition of material to increase the inner diameter and a change to the laser marking and passivation process. |
P110016/S015 2/26/15 Special |
FlexAbility Ablation Catheter | St. Jude Medical Plymouth, MN 55442 |
Approval for an additional manufacturing inspection step. |
P110032/S010 2/3/15 Real-Time |
Aorfix and Aorfix Plus AAA Flexible Stent Graft System with Aorflex Delivery Device | Lombard Medical Technologies Inc. Irvine, CA 92618 |
Approval for a line extension that would include two larger size stent grafts. The device, as modified, will be marketed under the trade name Aorfix and Aorfix Plus AAA Flexible Stent Graft System with Aorflex Delivery Device and is indicated for treatment of patients with abdominal aortic and aorto-iliac aneurysms having vascular morphology suitable for endovascular repair, including: 1) Adequate iliac or femoral access that is compatible with vascular access techniques, implants, and accessories. 2) Aortic neck landing zone diameters with a range of 19 mm to 33 mm. 3) Non aneurysmal proximal neck center-line length of > 15 mm. 4) Infrarenal aortic neck angulations including those up to and including 90°. 5) Common iliac landing zone diameters with a range of 9mm to 19mm. 6) Distal fixation length of > 15 mm. |
P110041/S001 2/2/15 Real-Time |
ADVIA Centaur® HBsAgII | Siemens Healthcare Diagnostics East Walpole, MA 02032 |
Approval for an additional surfactant to the Lite Reagent. |
P120006/S015 2/2/15 180-Day |
Trivascular, Inc. Ovation Prime Abdominal Stent Graft System, Trivascular, Inc. Ovation iX Iliac Stent Graft |
Trivascular, Inc. Santa Rosa, CA 95403 |
Approval the to add a larger diameter iliac limb and iliac extension, a longer length iliac limb, and decrease the delivery system profile for each iliac limb and iliac extensions. The device, as modified, will be marketed under the trade name Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft and is indicated for the treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including:
iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices and/or accessories; 2) Proximal aortic landing zone: a) with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13mm below the inferior renal artery, and b) with an aortic angle of < 60 degrees if proximal neck is 10 ≥ mm degrees if proximal neck is < 10 mm; and 3) Distal iliac landing zone: a) with a length of at least 10 mm, and b) with an inner wall diameter of no less than 8 mm and no greater than 25 mm. |
P120010/S024 2/19/15 Real-Time |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Approval changes to the design and manufacturing of the needle for the Medtronic MiniMed 530G System Enlite Glucose Sensor (MMT-7008A, MMT- 7008B); the specifically proposed changes which influence the Enlite needle to introduce a bevel at the needle tip and increase needle sharpness. |
P120010/S026 2/4/15 Real-Time |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Approval for replacing the Test Plug with two Watertight Testers in the MiniLink Kit. |
P120010/S030 2/4/15 Real-Time |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Approval for changes to the sensor base which included; the addition of anti-rotation pins and snap arms, modification of the o-ring gland; width, position, and diameter, an increase to the bore size and addition of a bore taper, a sensor through-hole size increase, and connector pad surface height increase, on the EnliteTM Glucose Sensor (MMT- 7008) of the MiniMed 530G System. |
P120010/S036 2/13/15 Real-Time |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Approval for changes to the pump motor sintered bearing material. |
P130005/S002 2/12/15 180-Day |
Diamondback 360 Coronary Orbital Atherectomy System (OAS) | Cardiovascular Systems, Inc. St. Paul, MN 55112 |
Approval for changes to the design of the orbital atherectomy system pump (OAS Pump Model SIP-3000) including the addition of a secondary motor feedback printed circuit board, the addition of a shroud over the AC power cord connection, the addition of a 100% inspection of Power Jack retention, and the selection of an alternate vendor for the Timer Component. |
P130008/S002 2/5/15 180-Day |
Inspire Upper Airway Stimulation Therapy | Inspire Medical Systems, Inc. Maple Grove, MN 55369 |
Approval for an update to the tablet hardware and operating system of the Model 2740 Physician Programmer, and related changes to the Model 2740 programmer manual. |
P130017/S001 2/2/15 180-Day |
Cologuard | Exact Sciences, Inc. Madison, WI 53719 |
Approval of the post-approval study protocol. |
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 |
---|---|---|---|
P810002/S093 2/10/15 |
Regent, Standard, and Masters Series Mechanical Heart Valves | St. Jude Medical, Inc. St Paul, MN 55117 |
Implementation of new equipment for silicon weight percent measurement of the orifice and leaflet components of SJM mechanical heart valves. |
P810002/S094 2/19/15 |
St. Jude Medical Mechanical Heart Valves | St. Jude Medical, Inc. St Paul, MN 55117 |
Implementation of an update to the receiving inspection criteria of seal strength for the lid material used in device packaging. |
P840001/S288 2/6/15 |
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Leads | Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Changes to the software and procedures for the die sorter equipment. |
P840001/S289 2/10/15 |
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Supplier facility change and a change in doping material application process. |
P840001/S290 2/11/15 |
RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change the inspection criteria on an insulator subassembly. |
P840001/S291 2/19/15 |
RestoreAdvanced Neurostimulator, RestoreAdvanced SureScan MRI Rechargeable Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change two manufacturing inspection steps. |
P840001/S292 2/20/15 |
RestoreUltra Neurostimulator, RestoreSensor Neurostimulator, RestoreUltra SureScan MRI Rechargeable Neurostimulator, RestoreSensor SureScan MRI Recharge Neurostimulator |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Change the epoxy mix ratio and the equipment used to dispense the epoxy. |
P860004/S218 2/6/15 |
SynchroMed Infusion System | Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Changes to the software and procedures for the die sorter equipment. |
P860004/S219 2/6/15 |
SynchroMed Infusion System | Medtronic, Incorporated Neuromodulation Minneapolis, MN 55432 |
Vascutek to manufacture the entire mesh pouch with yarn supplied by a supplier. |
P860004/S220 2/10/15 |
SychroMed Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Supplier facility change and a change in doping material application process. |
P860057/S132 2/10/15 |
Carpentier-Edwards PERIMOUNT Bioprostheses | Edwards Lifesciences, LLC Irvine, CA 92614 |
Upgrade to the labeling software used to generate finished device labels. |
P870076/S016 2/19/15 |
Falope-Ring Band Applicator Kits | Gyrus ACMI, Inc. Southborough, MA 01772 |
Addition of a package sealing equipment. |
P910001/S077 2/5/15 |
Spectranetics CVX-300 Excimer Laser System | Spectranetics Corp. Colorado Springs, CO 80921 |
Add an additional component supplier for the CVX-300 and CVX-300-P laser system. |
P910023/S353 2/18/15 |
Current DR, Current DR RF, Current Accel DR, Current+ DR, Current VR, Current VR RF, Current Accel VR, Current+ VR, Ellipse DR, Ellipse VR, Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR, |
St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342 |
Alternate case lid supplier for high voltage capacitors utilized in the devices. |
P920015/S047 2/7/15 |
Sprint Quattro Leads | Medtronic CRDM Mounds View, MN 55112 |
Second source supplier for five lead components (Screw-in Connector Ring, Rotating Connector Pin, CF-1 Electrode Pin, Screw-in Connector Ring, and Four Pole Lead Connector Ring) used in the devices. |
P930039/S124 2/7/15 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead | Medtronic CRDM Mounds View, MN 55112 |
Second source supplier for five lead components (Screw-in Connector Ring, Rotating Connector Pin, CF-1 Electrode Pin, Screw-in Connector Ring, and Four Pole Lead Connector Ring) used in the devices. |
P950020/S071 2/4/15 |
Flextome Cutting Balloon Microsurgical Dilatation Device | Boston Scientific Corp. Maple Grove, MN 55311 |
Update to the adhesive mixing software and associated manufacturing work instructions. |
P950037/S146 2/2/15 |
Dextrus, Setrox, TILDA, Safio |
Biotronik, Inc. Lake Oswego, OR 97035 |
Change from a manual to an automated process for the ejection of molded parts of the lead fixation helix in the devices. |
P950037/S147 2/20/15 |
Selox JT, Selox ST, Setrox S, TILDA, Safio S, TILDA JT, TILDA T, Dextrus |
Biotronik, Inc. Lake Oswego, OR 97035 |
Replace finished steroid eluting leads with lead dummies for the particulate matter testing. |
P960009/S213 2/6/15 |
Activa Deep Brain Stimulation Therapy | Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Changes to the software and procedures for the die sorter equipment. |
P960009/S214 2/10/15 |
Activa Deep Brain Stimulation Therapy System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Supplier facility change and a change in doping material application process. |
P960009/S215 2/11/15 |
ACTIVA Family Deep Brain Stimulations | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change the inspection criteria on an insulator subassembly. |
P960009/S216 2/20/15 |
ACTIVA Family Deep Brain Stimulations | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change the epoxy mix ratio and the equipment used to dispense the epoxy. |
P960040/S342 2/23/15 |
Dynagen ICD, Inogen ICD, Origen ICD, Punctua ICD, Energen ICD, Incepta ICD | Boston Scientific Corporation Saint Paul, MN 55112 |
Add an additional supplier for low voltage capacitors used in the devices. |
P970004/S188 2/6/15 |
InterStim Therapy System | Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Changes to the software and procedures for the die sorter equipment. |
P970004/S189 2/10/15 |
InterStim Therapy System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Supplier facility change and a change in doping material application process. |
N970012/S104 2/12/14 |
Inflatable Penile Prosthesis with InhibiZone Treatment | American Medical Systems, Inc. Minnetonka, MN 55343 |
Implementation of alternative automated manufacturing mixing equipment. |
P970020/S081 2/6/15 |
MULTI-LINK ULTRA Coronary Stent Systems | Abbott Vascular Inc. Santa Clara, CA 95054 |
Implement an alternate digestion system used to prepare purchased stainless steel samples for chemical characterization. |
P980016/S516 2/9/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an additional weld strength proof test. |
P980016/S517 2/7/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VVR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Update the cleaning process at a supplier for the ceramic alumina insulator seat in feedthrough assembly. |
P980016/S518 2/7/15 |
Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Maximo II, Protecta, Protecta XT, Secura, Virtuoso II DR/VR ICDs |
Medtronic, Inc. Mounds View, MN 55112 |
Minor update to the software configuration of the integrated circuit die sorter equipment. |
P980016/S519 2/12/15 |
Evera S DR/VR and Evera XT DR/VR ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new 3D laser marker. |
P980016/S520 2/19/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Automation of a visual inspection of the connector assembly. |
P980016/S522 2/26/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing process and specification of tantalum pins. |
P980016/S523 2/23/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD |
Medtronic, Inc. Mounds View, MN 55112 |
Add an additional supplier for tantalum substrates for capacitors used in the devices. |
P980016/S524 2/23/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD |
Medtronic, Inc. Mounds View, MN 55112 |
Use of a new automated inspection system for the devices final package tray. |
P980016/S525 2/27/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD |
Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing process changes for XE161 crystal component used in the devices. |
P980016/S529 2/23/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD |
Medtronic, Inc. Mounds View, MN 55112 |
Add a vapor degreaser to the hybrid build clean process. |
P980023/S063 2/2/15 |
Linoxsmart, VOLTA | Biotronik, Inc. Lake Oswego, OR 97035 |
Change from a manual to an automated process for the ejection of molded parts of the lead fixation helix in the devices. |
P980023/S064 2/20/15 |
Linoxsmart SD, Linoxsmart S, Linoxsmart S DX, Linoxsmart T, Linoxsmart TD, VOLTA 1CR, VOLTA 2CR, VOLTA 1CT, VOLTA 2CT, Protego SD, Protego TD, Protego S, Protego T |
Biotronik, Inc. Lake Oswego, OR 97035 |
Replace finished steroid eluting leads with lead dummies for the particulate matter testing. |
P980035/S405 2/7/15 |
Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Minor update to the software configuration of the integrated circuit die sorter equipment. |
P980035/S406 2/12/15 |
Adapta, Versa, Sensia, Advisa DR, and Advisa DR MRI IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new 3D laser marker. |
P980035/S407 2/19/15 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Automation of a visual inspection of the connector assembly. |
P980035/S408 2/23/15 |
Advisa DR IPG, Advisa DR MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Add an additional supplier for tantalum substrates for capacitors used in the devices. |
P980035/S409 2/23/15 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG |
Medtronic, Inc. Mounds View, MN 55112 |
Use of a new automated inspection system for the devices final package tray. |
P980035/S410 2/27/15 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing process changes for XE161 crystal component used in the devices. |
P980035/S414 2/23/15 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Add a vapor degreaser to the hybrid build clean process. |
P990065/S008 2/27/15 |
SIR-Spheres® Microspheres | Sirtex Medical Limited AUSTRALIA 2060 |
Addition of a new cleanroom with two new production hot cells and associated equipment to existing manufacturing space. |
P000023/S011 2/13/15 |
TMJ Fossa-Eminence and Condylar Prosthesis System | Nexus CMF Golden, CO 80401 |
Replace disinfectant solution Cidex 28 day with Microcide 28 H2O for disinfection reusable instruments; allow for the cleaning of newly manufactured product with disinfection. |
P000035/S011 2/13/15 |
TMJ Fossa-Eminence Prosthesis System | Nexus CMF Golden, CO 80401 |
Replace disinfectant solution Cidex 28 day with Microcide 28 H2O for disinfection reusable instruments; allow for the cleaning of newly manufactured product with disinfection. |
P000053/S055 2/12/15 |
AMS 800 Urinary Control System with InhibiZone Treatment | American Medical Systems, Inc. Minnetonka, MN 55343 |
Implementation of alternative automated manufacturing mixing equipment. |
P010012/S384 2/23/15 |
Dynagen CRT-D, Inogen CRT-D, Origen CRT-D, Punctua CRT-D, Energen CRT-D, Incepta CRT-D | Boston Scientific Corporation Saint Paul, MN 55112 |
Add an additional supplier for low voltage capacitors used in the devices. |
P010014/S050 2/19/15 |
Oxford Partial Knee System | Biomet, Inc. Warsaw, IN 46582 |
Removal of a step from the manufacturing process. |
P010015/S256 2/2/15 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing process, a new measurement system, for the Battery Case Subassembly for the devices. |
P010015/S257 2/9/15 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an additional weld strength proof test. |
P010015/S258 2/7/15 |
Consulta, Syncra, Viva CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Minor update to the software configuration of the integrated circuit die sorter equipment. |
P010015/S259 2/19/15 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
Medtronic, Inc. Mounds View, MN 55112 |
Automation of a visual inspection of the connector assembly. |
P010015/S260 2/23/15 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Add an additional supplier for tantalum substrates for capacitors used in the devices. |
P010015/S261 2/23/15 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
Medtronic, Inc. Mounds View, MN 55112 |
Use of a new automated inspection system for the devices final package tray. |
P010015/S262 2/27/15 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing process changes for XE161 crystal component used in the devices. |
P010015/S266 2/23/15 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
Medtronic, Inc. Mounds View, MN 55112 |
Add a vapor degreaser to the hybrid build clean process. |
P010031/S480 2/9/15 |
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an additional weld strength proof test. |
P010031/S481 2/7/15 |
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Update the cleaning process at a supplier for the ceramic alumina insulator seat in feedthrough assembly. |
P010031/S482 2/7/15 |
Brava, Brava Quad, Concerto II, Consulta, Maximo II, Protecta, Protecta XT, Viva Quad S, Viva Quad XT, Viva S, Viva XT CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Minor update to the software configuration of the integrated circuit die sorter equipment. |
P010031/S483 2/12/15 |
Brava, Brava Quad, Viva S/XT, and Viva Quad S/XT CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new 3D laser marker. |
P010031/S484 2/19/15 |
Brava, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Automation of a visual inspection of the connector assembly. |
P010031/S486 2/26/15 |
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing process and specification of tantalum pins. |
P010031/S487 2/23/15 |
Brava CRT-D, Brava CRT-D, Brava Quad CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Add an additional supplier for tantalum substrates for capacitors used in the devices. |
P010031/S488 2/23/15 |
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Use of a new automated inspection system for the devices final package tray. |
P010031/S489 2/27/15 |
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing process changes for XE161 crystal component used in the devices. |
P010031/S494 2/23/15 |
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Add a vapor degreaser to the hybrid build clean process. |
P010032/S095 2/27/15 |
Tripole™ 16 Leads, Tripole™ 16C Lead, Lamitrode™ 44 Lead, Lamitrode™ 44 Lead, Lamitrode™ Lead, Lamitrode™ 88 Lead |
St. Jude Medical Plano, TX 75024 |
Manufacturing process changes applicable to short electrodes. |
P020047/S061 2/6/15 |
MULTI-LINK VISION, MINI VISION, MULTI-LINK 8 Coronary Stent Systems | Abbott Vascular Inc. Santa Clara, CA 95054 |
Implement an alternate digestion system used to prepare purchased stainless steel samples for chemical characterization. |
P030017/S212 2/25/15 |
Precision Spectra Spinal Cord Stimulator System | Boston Scientific Neuromodulation Valencia, CA 91355 |
Change to move existing packaging area and adhesive bonding process to new clean room at current supplier. |
P030026/S029 2/12/15 |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator | Ortho-Clinical Diagnostics Incorporated Rochester, NY 14626 |
Change to scale up the manufacturing process for a device component. |
P030036/S076 2/7/15 |
SelectSecure Lead | Medtronic CRDM Mounds View, MN 55112 |
Second source supplier for five lead components (Screw-in Connector Ring, Rotating Connector Pin, CF-1 Electrode Pin, Screw-in Connector Ring, and Four Pole Lead Connector Ring) used in the devices. |
P030054/S282 2/18/15 |
Promote, Promote Accel, Promote RF, Promote Q, Promote Quadra, Promote+, Quadra Assura, Unify, Unify Assura, Unify Quadra |
St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342 |
Alternate case lid supplier for high voltage capacitors utilized in the devices. |
P040012/S054 2/6/15 |
RX Acculink Carotid Stent System | Abbott Vascular Inc. Santa Clara, CA 95054 |
Implement an alternate digestion system used to prepare purchased stainless steel samples for chemical characterization. |
P040021/S026 2/12/15 |
Biocor, Epic, and Epic Supra Valve | St. Jude Medical, Inc. St Paul, MN 55117 |
Five new tissue suppliers. |
P050006/S045 2/19/15 |
Gore HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Modification to the delivery catheter liner resin. |
P070008/S059 2/20/15 |
CELERITY 2D, CELERITY 3D, CELERITY Pilot, Corox OTW, Corox OTW-S |
Biotronik, Inc. Lake Oswego, OR 97035 |
Replace finished steroid eluting leads with lead dummies for the particulate matter testing. |
P070015/S127 2/6/15 |
XIENCE V Everolimus Eluting Coronary Stent Systems | Abbott Vascular Inc. Santa Clara, CA 95054 |
Implement an alternate digestion system used to prepare purchased stainless steel samples for chemical characterization. |
P080025/S084 2/6/15 |
InterStim Therapy System | Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Changes to the software and procedures for the die sorter equipment. |
P080025/S085 2/10/15 |
InterStim Therapy System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Supplier facility change and a change in doping material application process. |
P090013/S166 2/10/15 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Transfer of a secondary suppliers manufacturing facility and associated boron doping process change. |
P090013/S167 2/7/15 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Minor update to the software configuration of the integrated circuit die sorter equipment. |
P090013/S168 2/7/15 |
CapSureFix MRI Lead | Medtronic CRDM Mounds View, MN 55112 |
Second source supplier for five lead components (Screw-in Connector Ring, Rotating Connector Pin, CF-1 Electrode Pin, Screw-in Connector Ring, and Four Pole Lead Connector Ring) used in the devices. |
P090013/S169 2/12/15 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new 3D laser marker. |
P090013/S170 2/19/15 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Automation of a visual inspection of the connector assembly. |
P090013/S171 2/23/15 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Add an additional supplier for tantalum substrates for capacitors used in the devices. |
P090013/S172 2/23/15 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new automated inspection system for the devices final package tray. |
P090013/S173 2/27/15 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing process changes for XE161 crystal component used in the devices. |
P090013/S176 2/23/15 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Add a vapor degreaser to the hybrid build clean process. |
P100022/S012 2/26/15 |
Zilver PTX Drug-Eluting Peripheral Stent | Cook Medical Incorporated Bloomington, IN 47402 |
Change to the pusher band location on the stent delivery system. |
P100023/S113 2/4/15 |
ION® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Update to the annual stability protocol. |
P100026/S029 2/19/15 |
NeuroPace RNS System | NeuroPace, Inc. Mountain View, CA 94043 |
Add alternate test equipment for batteries. |
P100029/S19 2/12/15 |
Trifecta Valve | St. Jude Medical, Inc. St Paul, MN 55117 |
Five new tissue suppliers. |
P100041/S063 2/10/15 |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
Upgrade to the labeling software used to generate finished device labels. |
P100041/S064 2/27/15 |
Edwards SAPIEN Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Installation of process water loop (Loop3) which has been installed to extend the currently validated process water system for the clean room used to manufacture the THV accessories at the Edwards Draper facility. |
P110019/S074 2/6/15 |
XIENCE PRIME Everolimus Eluting Coronary Stent Systems, XIENCE Xpedition Everolimus Eluting Coronary Stent System | Abbott Vascular Inc. Santa Clara, CA 95054 |
Implement an alternate digestion system used to prepare purchased stainless steel samples for chemical characterization. |
P110021/S050 2/10/15 |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
Upgrade to the labeling software used to generate finished device labels. |
P110021/S051 2/27/15 |
Edwards SAPIEN Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Installation of process water loop (Loop3) which has been installed to extend the currently validated process water system for the clean room used to manufacture the THV accessories at the Edwards Draper facility. |
P110027/S004 2/13/15 |
therascreen KRAS RGQ PCR Kit | QIAGEN Manchester Ltd. Manchester, UK M15 6SH |
New assembly line for manufacturing (assembling) QIAamp MinElute spin columns used to isolate and purify DNA. |
P110027/S005 2/19/15 |
therascreen® KRAS RGQ PCR Kit | QIAGEN Manchester Ltd. Manchester, UK M15 6SH |
Change of filling process for Proteinase K in the QIAamp DSP DNA FFPE Tissue kit from a manual to an automated process at the Hilden, Germany facility. |
P110028/S014 2/6/15 |
Absolute Pro Vascular Stent System | Abbott Vascular Inc. Santa Clara, CA 95054 |
Implement an alternate digestion system used to prepare purchased stainless steel samples for chemical characterization. |
P110035/S029 2/9/15 |
Epic Vascular Self-Expanding Stent System | Boston Scientific Corp. Maple Grove, MN 55311 |
New plasma unit used during the rack bonding process for the Epic Vascular Self-Expanding Nitinol Stent System. |
P120010/S057 2/27/15 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Removal of a conductivity test for a solution used on the manufacture of Enlite sensors, the creation of a new part number for this solution and the removal of alternate part number allowed for Enlite sensors manufacture. The Enlite sensor is a component of the MiniMed 530G system. |
P120010/S059 2/25/15 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Change to automate a process to press the gearbox shafts into the sun and planetary wheels of the 530G insulin pump drive motor. The 530G insulin pump is a component of the MiniMed 530G system. |
P120010/S060 2/25/15 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Changes to the sterilization process parameters used for the Enlite Glucose Sensor (MMT-7008A). The Enlite Glucose Sensor is a component of the MiniMed 530G System. |
P120022/S006 2/13/15 |
therascreen EGFR RGQ PCR Kit | QIAGEN Manchester Ltd. Manchester, UK M15 6SH |
New assembly line for manufacturing (assembling) QIAamp MinElute spin columns used to isolate and purify DNA. |
P120022/S007 2/19/15 |
therascreen® EGFR RGQ PCR Kit | QIAGEN Manchester Ltd. Manchester, UK M15 6SH |
Change of filling process for Proteinase K in the QIAamp DSP DNA FFPE Tissue kit from a manual to an automated process at the Hilden, Germany facility. |
P130008/S005 2/27/15 |
Inspire Upper Airway Stimulation Therapy System | Inspire Medical Systems, Inc. Maple Grove, MN 55369 |
Changes to the lead welding, crimping, and molding processes at the firm’s contract manufacturer. |
P130009/S023 2/5/15 |
Edwards SAPIEN XT Transcatheter Heart Valve-Edwards Expandable Introducer Sheath Set | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Multiple modifications to the manufacturing of the introducer sheath related to the marker band on the sheath shaft. |
P130009/S024 2/10/15 |
Edwards SAPIEN XT Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
Upgrade to the labeling software used to generate finished device labels. |
P130009/S025 2/25/15 |
Edwards Sapien XT Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
New nose tip supplier for the Ascendra+ delivery system. |
P130009/S026 2/13/15 |
Edwards SAPIEN XT™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Extend the shelf life of the polytetra-fluoroethylene round suture from 5 years to 8 years. |
P130009/S027 2/27/15 |
Edwards SAPIEN XT™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Installation of process water loop (Loop3) which has been installed to extend the currently validated process water system for the clean room used to manufacture the THV accessories at the Edwards Draper facility. |
P130026/S001 2/26/15 |
Tacticath Quartz Ablation Catheter | St. Jude Medical St. Paul, MN 55117 |
Use of an alternative supplier for the distal optical fiber component used in the TactiCath Quartz ablation catheter. |
P130030/S009 2/25/15 |
REBEL Monorail and Over-the-Wire Platinum Chromium Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Remove the inner component trimming process. |