Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 56
Summary of PMA Originals Under Review
Total Under Review: 50
Total Active: 19
Total On Hold: 31
Summary of PMA Supplements Under Review
Total Under Review: 529
Total Active: 354
Total On Hold: 175
Summary of All PMA Submissions Received
Originals: 1
Supplements: 38
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 56
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 131.2
FDA Time: 104.9 Days MFR Time: 26.3 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P100009 10/24/13 |
MitraClip Clip Delivery System (MitraClip CDS) | Abbott Vascular Menlo Park, CA 94025 |
Approval for the MitraClip Clip Delivery System (MitraClip CDS). This device is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR > 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation. |
P110033 10/22/13 |
JUVEDERM VOLUMA™ XC | Allergan Goleta, CA 93117 |
Approval for the JUVEDERM VOLUMA TM XC. This device is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the midface in adults over the age of 21. |
P130005 10/21/13 |
Diamondback 360 Coronary Orbital Atherectomy System; consisting of: Diamondback 360 Coronary Orbital Atherectomy Device (DBEC-125, DBEC-150), Saline Infusion Pump (SIP-3000, SWS-100, SPC-100), Viperwire Advance Coronary Guide Wire (GWC-12325LG-FLP), and ViperSlide Lubricant (VPR-SLD2) |
Cardiovascular Systems, Inc. St. Paul, MN 55112 |
Approval for the Diamondback 360 Coronary Orbital Atherectomy System (OAS). The device is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting due to de novo, severely calcified coronary artery lesions. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P830055/S139 10/29/13 Special |
LCS® Total Knee System | DePuy Orthopaedics, Incorporated Warsaw, IN 46581 |
Approval for changes to the labeling (surgical technique). Additional instructions on the use of the ATTUNE Knee System Balanced Sizer are being added to the existing surgical technique based on clinical experience gained by surgeons. |
P850048/S035 10/17/13 Special |
Access Hybritech PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of new warnings to the Access 2 instrument manuals. |
P850048/S036 10/17/13 Special |
Access Hybritech PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of periodic reboots in the maintenance schedule and revising the maintenance instructions for the UniCelDxI Immunoassay Systems. |
P870072/S054 10/11/13 180-Day |
Thoratec® Ventricular Assist Device (VAD) System TLC II Car Power Adapter | Thoratec Corporation Pleasanton, CA 94588 |
Approval for a new Car Power Adapter for the TLC II Portable VAD Driver. |
P890003/S283 10/7/13 Real-Time |
CareLink Remote Home Monitor | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a firmware update to the Model 2490C CareLink Remote Home Monitor for the devices. |
P890003/S284 10/15/13 Real-Time |
CareLink Remote Home Monitor, CareLink Remote Home Monitor, CardioSight Reader, CareLink Express Monitor | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a firmware update to version CM2490C_10v5 for the Model 2490C CareLink Remote Home Monitor and for a firmware update to version CM2490G_14v2 for the 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Cardiosight Reader, and 2020B CareLink Express Monitor for the devices. |
P920047/S060 10/7/13 Special |
EPT-1000 Cardiac Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for IEC 60601-1 3rd Edition labeling implementation to the Blazer II, Blazer II XP/HTD, Blazer Prime XP/HTD and Chilli II Cardiac Ablation Catheters and Cables. |
P970004/S155 10/22/13 180-Day |
InterStim Therapy for Urinary Control | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changes to the labeling and product specification related to the use of diagnostic ultrasound imaging to help guide the insertion of the foramen needle into one of the sacral foramina during the acute test stimulation procedure. |
P970018/S027 10/16/13 Special |
BD PrepStain™ System | BD Diagnostics Durham, NC 27703 |
Approval for labeling revisions to include warnings related to the material safety of reagents used for preparation of slides to the BD PrepStain™ System . |
P970038/S024 10/17/13 Special |
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of new warnings to the Access 2 instrument manuals. |
P970038/S025 10/17/13 Special |
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of periodic reboots in the maintenance schedule and revising the maintenance instructions for the UniCelDxI Immunoassay Systems. |
P970051/S104 10/23/13 180-Day |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for the following changes: a modification to the Freedom sound processor, a change in the Freedom bodyworn cable o-ring, a change to Freedom bodyworn cable clip, a change to the Freedom battery pack, a change to the Freedom rechargeable battery, and a modification of the surgical tool kit instructions for the CI24RE and CI422 series implants. |
P970051/S105 10/23/13 135-Day |
Nucleus 24 Cochlear Implant System – CI422 Implant | Cochlear Americas Centennial, CO 80111 |
Additional supplier of a component and additional specifications on cleaning, packaging and inspection of these components. |
P980003/S041 10/7/13 Special |
Chilli Cooled Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for IEC 60601-1 3rd Edition labeling implementation to the Blazer II, Blazer II XP/HTD, Blazer Prime XP/HTD and Chilli II Cardiac Ablation Catheters and Cables. |
P980016/S426 10/4/13 180-Day |
Evera S DR, S VR, XT DR, and XT VR ICD’s | Medtronic, Inc. Mounds View, MN 55112 |
Approval for adding non-Medtronic defibrillation leads to Right Ventricular Lead Integrity Alert (RV LIA) labeling. |
P980016/S431 10/7/13 Real-Time |
Virtuoso DR, Virtuoso VR, Secura DR, Maximo II DR, Virtuoso II DR, Secura VR, Maximo II VR, Virtuoso II VR, Protecta XT DR, Protecta DR, Protecta XT VR, Protecta VR, Evera XT DR, Evera S DR, Evera XT VR, Evera S VR | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a firmware update to the Model 2490C CareLink Remote Home Monitor for the devices. |
P980016/S433 10/15/13 Real-Time |
Virtuoso DR, Virtuoso VR, Secura DR, Maximo II DR, Virtuoso II DR, Secura VR, Maximo II VR, Virtuoso II VR, Protecta XT DR, Protecta DR, Protecta XT VR, Protecta VR, Evera XT DR, Evera S DR, Evera XT VR, Evera S VR, Entrust, Virtuoso, Intrinsic, Marquis, Maximo, Maximo II, Secura, Virtuoso II, Insync Marquis | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a firmware update to version CM2490C_10v5 for the Model 2490C CareLink Remote Home Monitor and for a firmware update to version CM2490G_14v2 for the 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Cardiosight Reader, and 2020B CareLink Express Monitor for the devices. |
P980016/S435 10/31/13 180-Day |
Evera S, Evera XT, Evera XT, Protecta, Protecta XT | Medtronic, Inc. Mounds View, MN 55112 |
Approval for labeling updates for additional information regarding usage of wireless telemetry. |
P980016/S437 10/29/13 Real-Time |
Evera XT DR, Evera S DR, Evera XT VR, Evera S VR | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a minor design change in the Multilayer Ceramic Capacitors made by a second tier supplier which are used in the devices. |
P980022/S138 10/31/13 Special |
Paradigm® REAL-Time System Paradigm® REAL-Time Revel System |
Medtronic MiniMed Northridge, CA 91325 |
Approval of labeling changes to the User Guide for the Paradigm REAL-Time Insulin Pumps (models MMT-522, MMT-522K, MMT-722, and MMT-722K), and for the Paradigm REAL-Time Revel Insulin Pumps (models MMT-523, MMT-523K, MMT-723, and MMT-723K). The Paradigm REAL-Time Insulin Pumps are components of the Paradigm REAL-Time System and the Paradigm REAL-Time Revel Insulin Pumps are components of the Paradigm REAL-Time Revel Systems. |
P980035/S341 10/15/13 Real-Time |
Advisa, Enrhythm MRI | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a firmware update to version CM2490C_10v5 for the Model 2490C CareLink Remote Home Monitor and for a firmware update to version CM2490G_14v2 for the 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Cardiosight Reader, and 2020B CareLink Express Monitor for the devices. |
P980041/S025 10/17/13 Special |
Access AFP Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of new warnings to the Access 2 instrument manuals. |
P980041/S026 10/17/13 Special |
Access AFP Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of periodic reboots in the maintenance schedule and revising the maintenance instructions for the UniCelDxI Immunoassay Systems. |
P990075/S022 10/8/13 180-Day |
Mentor Saline-Filled and Spectrum Breast Implants | Mentor Worldwide, LLC Santa Barbara, CA 93111 |
Approval for updated labeling incorporating information on Anaplastic Large Cell Lymphoma (ALCL). |
P990081/S020 10/25/13 135-Day |
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody System | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for addition of a new supplier of bioconjugates for the ultraView Universal DAB Detection kit. The detection kit is part of the PATHWAY Anti-HER 2/neu Rabbit Monoclonal Primary Antibody (4B5). |
P000029/S075 10/17/13 180-Day |
DEFLUX INJECTABLE GEL | Salix Pharmaceuticals, Inc. Raleigh, NC 27615 |
Approval for Labeling Changes, which add two additional techniques for Injection, The HIT and Double-HIT. |
P010015/S212 10/15/13 Real-Time |
Consulta CRT-P, Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a firmware update to version CM2490C_10v5 for the Model 2490C CareLink Remote Home Monitor and for a firmware update to version CM2490G_14v2 for the 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Cardiosight Reader, and 2020B CareLink Express Monitor for the devices. |
P010031/S387 10/4/13 180-Day |
Brava, Viva S, and Viva XT CRT-D’s | Medtronic, Inc. Mounds View, MN 55112 |
Approval for adding non-Medtronic defibrillation leads to Right Ventricular Lead Integrity Alert (RV LIA) labeling. |
P010031/S392 10/7/13 Real-Time |
Consulta CRT D, Maximo II CRT-D, Concerto II CRT-D, Concerto CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva XT CRT-D, Viva S CRT-D, BRAVA CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a firmware update to the Model 2490C CareLink Remote Home Monitor for the devices. |
P010031/S394 10/15/13 Real-Time |
Consulta CRT D, Maximo II CRT-D, Concerto II CRT-D, Concerto CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva XT CRT-D, Viva S CRT-D, BRAVA CRT-D, Concerto, Consulta, Insync II Marquis, Insync III Marquis, Insync Maximo, InSync Sentry, InSync Marquis, InSync II Protecta | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a firmware update to version CM2490C_10v5 for the Model 2490C CareLink Remote Home Monitor and for a firmware update to version CM2490G_14v2 for the 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Cardiosight Reader, and 2020B CareLink Express Monitor for the devices. |
P010031/S396 10/31/13 180-Day |
Brava, Protecta, Protecta XT, Viva S, Viva XT | Medtronic, Inc. Mounds View, MN 55112 |
Approval for labeling updates for additional information regarding usage of wireless telemetry. |
P010031/S398 10/29/13 Real-Time |
Viva XT CRT-D, Viva S CRT-D, BRAVA CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a minor design change in the Multilayer Ceramic Capacitors made by a second tier supplier which are used in the devices. |
P010032/S067 10/15/13 Real-Time |
St. Jude Spinal Cord Stimulation System | St. Jude Medical Plano, TX 75024 |
Approval to increase the upper limit of the groove width and depth on the Penta electrode. |
P020014/S040 10/30/13 Special |
Essure System for Permanent Birth Control | Bayer HealthCare, LLC Milpitas, CA 95035 |
Approval for changes to the Patient Information Booklet to include additional information on risks of chronic pelvic pain and device migration. |
P020025/S044 10/7/13 Special |
EPT-1000xp Cardiac Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for IEC 60601-1 3rd Edition labeling implementation to the Blazer II, Blazer II XP/HTD, Blazer Prime XP/HTD and Chilli II Cardiac Ablation Catheters and Cables. |
P020050/S014 10/18/13 Real-Time |
WaveNet™ Planning Software for the WaveNet™ Network System for use with the Wave Light® EX500 Excimer Laser System and WaveLight® Analyzer II | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for the WaveNet™ Planning Software (WPS), a stand-alone user interface software system for the WaveLight® EX500 Excimer Laser System. The WPS enables the physician to plan surgical cases remotely in advance of the planned surgical date. |
P030008/S012 10/18/13 Real-Time |
WaveNet™ Planning Software for the WaveNet™ Network System for use with the Wave Light® EX500 Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for the WaveNet™ Planning Software (WPS), a stand-alone user interface software system for the WaveLight® EX500 Excimer Laser System. The WPS enables the physician to plan surgical cases remotely in advance of the planned surgical date. |
P040037/S050 10/18/13 180-Day |
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for the addition of a 25cm length for the 5-8mm diameter endoprostheses. The device, as modified, will be marketed under the trade name GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface and is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions up to 230 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm. The GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface are also indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. |
P050011/S005 10/29/13 Real-Time |
ADEPT Adhesion Reduction Solution (4% Icodextrin) | Baxter Healthcare Corporation Round Lake, IL 60073 |
Approval for a new polyvinylchloride storage bag for the ADEPT Adhesion Reduction Solution. |
P050044/S021 10/11/13 180-Day |
Vitagel RT | Stryker Orthobiologics Malvern, PA 19355 |
Approval for a new version of Vitagel where the bovine thrombin component is replaced with recombinant human thrombin. The product, as modified, will be marketed under the trade name Vitagel RT and is indicated in surgical procedures (other than neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. |
P060025/S012 10/2/13 Real-Time |
3f Aortic Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Approval for a change to the packaging system for the 3f Aortic Bioprosthesis, Model 1000. |
P060033/S075 10/15/13 135-Day |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a change to the Empower software application used to control the analytical chromatographic instruments for the analytical tests. |
P070026/S018 10/23/13 Real-Time |
DePuy Ceramax® Ceramic Total Hip System: Addition of Pinnacle™ 300 and Multi-hole II Acetabular Cup Components as Compatible Components | DePuy Orthopaedics, Incorporated Warsaw, IN 46581 |
Approval for addition of Pinnacle 300 and Multi-hole II Acetabular Cup Components as compatible components. |
P070026/S019 10/24/13 Real-Time |
CERAMAX® Ceramic Total Hip System | DePuy Orthopaedics, Incorporated Warsaw, IN 46581 |
Addition of a tamp extractor instrument. |
P080025/S051 10/22/13 180-Day |
InterStim Therapy for Bowel Control | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changes to the labeling and product specification related to the use of diagnostic ultrasound imaging to help guide the insertion of the foramen needle into one of the sacral foramina during the acute test stimulation procedure. |
P080026/S006 10/15/13 180-Day |
Abbott RealTime HBV | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for 1) the addition of an optional extended use feature to allow prepared amplification master mix and internal control to be used second time within 14 days of initial use if stored at 2°C to 8°C; 2) Improvements to the preparation and processing steps of the amplification master mix by the Abbott m2000spinstrument; and 3) Associated software revisions. |
P090013/S110 10/15/13 Real-Time |
Revo MRI | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a firmware update to version CM2490C_10v5 for the Model 2490C CareLink Remote Home Monitor and for a firmware update to version CM2490G_14v2 for the 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Cardiosight Reader, and 2020B CareLink Express Monitor for the devices. |
P090026/S008 10/17/13 Special |
Access Hybritech P2PSA Reagents on the Access Immunoassay System | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of new warnings to the Access 2 instrument manuals. |
P090026/S009 10/17/13 Special |
Access Hybritech P2PSA Reagents on the Access Immunoassay System | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of periodic reboots in the maintenance schedule and revising the maintenance instructions for the UniCelDxI Immunoassay Systems. |
P100010/S026 10/3/13 135-Day |
Arctic Front Catheters Arctic Front Advance Catheters |
Medtronic CryoCath LP Mounds View, MN 55112 |
Approval for a new process for incoming inspection of check valves. |
P100018/S008 10/22/13 Real-Time |
Pipeline™ Embolization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Irvine, CA 92618 |
Approval for a design change for the shorter Pipeline™ Embolization Devices (PED), model numbers FA-77XXX-XX, with lengths between 10mm and 20mm. This design change involves replacing the delivery core wire currently available on these shorter PED lengths (RM-00013-XX) with the delivery core wire currently available on the longer PED lengths (RM-00089-XX), model numbers FA-71XXX-XX, between 25mm and 35mm. |
P100022/S002 10/16/13 180-Day |
Zilver® PTX® Drug- Eluting Peripheral Stent (6-8mm x 40-120mm) | Cook Incorporated Bloomington, IN 47402 |
Approval for modifications to the drug coating process. |
P100022/S008 10/22/13 Real-Time |
Zilver® PTX® Drug- Eluting Peripheral Stent | Cook Incorporated Bloomington, IN 47402 |
Approval for tightening the drug potency specification and expansion of your device shelf-life from 6 months to 12 months. |
P100039/S001 10/3/13 180-Day |
ADVIA Centaur® Anti-HBs2 (aHBs2) Assay and ADVIA Centaur® Anti-HBs2 (aHBs2) Quality Control Material |
Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 |
Approval for the ADVIA Centaur Anti-HBs2 (aHBs2) Assay and ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA Centaur CP instrument. The device, as modified, will be marketed under the trade name ADVIA Centaur Anti-HBs2 (aHBs2) assay and ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material and is indicated for: ADVIA Centaur Anti-HBs2 (aHBs2) Assay – The ADVIA Centaur anti-HBs2 assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis B surface antigen in human adult, adolescent, and pediatric serum or plasma (EDT A, lithium-heparinized, or sodium-heparinized) and neonatal samples using the ADVIA Centaur CP system. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. This assay has not been FDA-cleared or approved for the screening of blood or plasma donors. ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material – For in vitro. diagnostic use in monitoring the performance of the Anti-HBs2 assay on the ADVIA Centaur Systems. The performance of the Anti-HBs2 quality control material has not been established with any other Anti-HBs assays. |
P110013/S012 10/15/13 135-Day |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a change to the Empower software application used to control the analytical chromatographic instruments for the analytical tests. |
P110042/S016 10/31/13 Real-Time |
Subcutaneous Implantable Defibrillator S-ICD System | Cameron Health, Inc. San Clemente, CA 92673 |
Approval for a supplier change for the high voltage capacitors used in the S-ICD System. |
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 |
---|---|---|---|
N970003/S156 10/10/13 |
ADVANTIO, INGENIO, VITALIO, FORMIO Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of new cleaners and cleaning solution for the Pulse Generator (PG) feedthru assembly process. |
P790005/S050 10/3/13 |
EBI OsteoGen Bone Growth Stimulators | Biomet Spine & Bone Healing Technologies Parsippany, NJ 07054 |
Use of a new water system monitoring test method. |
P830061/S097 10/10/13 |
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead | Medtronic CRDM Mounds View, MN 55112 |
Implementation of an automatic visual inspection system for labels received at incoming inspection. |
P830061/S098 10/17/13 |
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery products. |
P840001/S247 10/3/13 |
SCS Extensions; SCS Leads; SCS Leads; SCS Leads Pisces Family; SCS Leads Specify Family; SCS Screening Trialing Systems |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Updates to the current Final Pack Label Printing Equipment Controller, which is used during the sterile final package operation at Medtronic Puerto Rico Operations Company (MPROC) in Villalba, Puerto Rico. |
P840001/S248 10/10/13 |
Restore Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
New materials for the integrated circuit component. |
P840001/S249 10/15/13 |
PrimeAdvanced SureScan MRI Neurostimulator; RestoreUltra SureScan MRI Neurostimulator; RestoreAdvanced SureScan MRI Neurostimulator; RestoreSensor SureScan MRI Neurostimulator |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Modifications to the test sample size for certain connector components received from a component supplier. |
P840001/S250 10/23/13 |
SCS Programming Systems N’Vision Programmer, SCS Programming Systems Itrel EZ Programmer, SCS Programming Systems Synergy EZ Programmer |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Qualification of an alternate supplier for a critical device component. |
P840001/S251 10/22/13 |
Restore® Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Increase the use before date storage shelf life of the Tyvek lid packaging component used in the sterile packaging configuration of multiple implantable neuromodulation products. |
P840001/S252 10/10/13 |
Restore® Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use of SAP Enterprise Central Component 6 Enhancement Pack 5 at Medtronic Puerto Rico Operations Company, Juncos, and Puerto Rico. |
P840001/S253 10/30/13 |
SCS Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of a new header subassembly laser weld station. |
P850035/S036 10/3/13 |
SpF Implantable Spinal Fusion Stimulators | Biomet Spine & Bone Healing Technologies Parsippany, NJ 07054 |
Use of a new water system monitoring test method. |
P850089/S100 10/10/13 |
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead | Medtronic CRDM Mounds View, MN 55112 |
Implementation of an automatic visual inspection system for labels received at incoming inspection. |
P850089/S101 10/17/13 |
CapSure SP Z Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery products. |
P860004/S195 10/10/13 |
Synchromed Drug Pumps | Medtronic Neuromodulation Minneapolis, MN 55432 |
New materials for the integrated circuit component. |
P860004/S196 10/23/13 |
Drug Delivery Programming Systems N’Vision Programmer | Medtronic Neuromodulation Minneapolis, MN 55432 |
Qualification of an alternate supplier for a critical device component. |
P860004/S197 10/22/13 |
Synchromed Drug Infusion System-Neuromodulation Products | Medtronic Neuromodulation Minneapolis, MN 55432 |
Increase the use before date storage shelf life of the Tyvek lid packaging component used in the sterile packaging configuration of multiple implantable neuromodulation products. |
P860004/S198 10/10/13 |
Synchromed Drug Pumps | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use of SAP Enterprise Central Component 6 Enhancement Pack 5 at Medtronic Puerto Rico Operations Company, Juncos, and Puerto Rico. |
P860004/S199 10/30/31 |
Synchromed Infusion Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of a new header subassembly laser weld station. |
P860004/S200 10/28/13 |
SynchroMed II Implantable Infusion Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
SynchroMed II battery burn-in process be updated. |
P860057/S113 10/11/13 |
Carpentier-Edwards Perimount Pericardial Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of a new sterile wiper for use in cleanrooms and non-controlled environments to clean work surfaces and tools. |
P870056/S062 10/11/13 |
Carpentier-Edwards Porcine Aorta and Mitral Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of a new sterile wiper for use in cleanrooms and non-controlled environments to clean work surfaces and tools. |
P870077/S056 10/11/13 |
Carpentier-Edwards Duraflex Low Pressure Porcine Mitral | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of a new sterile wiper for use in cleanrooms and non-controlled environments to clean work surfaces and tools. |
P870078/S023 10/24/13 |
Hancock® Low Porosity Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a glutaraldehyde supplier and the addition of two new porcine tissue suppliers. |
P880086/S235 10/2/13 |
Accent Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Addition of a visual inspection during the assembly of the Accent and Anthem family of devices. |
P890003/S286 10/10/13 |
Prodigy IPG | Medtronic CRDM Mounds View, MN 55112 |
Change to the current battery burn-in test system processing, inspection methods, and associated software. |
P890003/S287 10/10/13 |
CapSure Lead | Medtronic CRDM Mounds View, MN 55112 |
Implementation of an automatic visual inspection system for labels received at incoming inspection. |
P890003/S288 10/17/13 |
CapSure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery products. |
P900056/S127 10/18/13 |
Rotablator Rotational Angioplasty System Guidewire with WireClip Torquer |
Boston Scientific Corporation Maple Grove, MN 55311 |
Change to implement the Central Monitoring System (CMS) at the sterilization facility. |
P900056/S128 10/18/13 |
Rotablator® Rotational Atherectomy System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P910001/S067 10/2/13 |
Spectranetics CVX-300 Excimer Laser Systems | Spectranetics Corporation Colorado Springs, CO 80921 |
Supplier change for the printed circuit board assemblies. |
P920015/S118 10/10/13 |
Sprint Quattro Lead | Medtronic CRDM Mounds View, MN 55112 |
Implementation of an automatic visual inspection system for labels received at incoming inspection. |
P920015/S116 10/10/13 |
HV Splitter Adaptor Kit, Sprint Quattro Leads | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an ellipsometry inspection step for ETFE jacketed wire and cable components. |
P920015/S119 10/17/13 |
HV Splitter Adaptor Kit, Sprint Quattro Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery products. |
P920015/S120 10/29/13 |
SPRINT QUATTRO SECURE LEADS | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the stock material of the electrode ring components. |
P920047/S061 10/18/13 |
Blazer II Cardiac Ablation Catheter and Cable | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to implement the Central Monitoring System (CMS) at the sterilization facility. |
P920047/S062 10/23/13 |
Blazer II/Blazer Prime HTD Ablation Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Change in the quality control (QC) inspections of the cardiac ablation system cables. |
P930031/S048 10/18/13 |
WALLSTENT® (TIPS) Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P930039/S093 10/10/13 |
CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, Vitatron Crystalline Lead | Medtronic CRDM Mounds View, MN 55112 |
Implementation of an automatic visual inspection system for labels received at incoming inspection. |
P930039/S094 10/17/13 |
CapSureFix Novus Lead, Vitatron Crystalline Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery Products. |
P940019/S041 10/18/13 |
WALLSTENT® (Iliac) Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P950005/S046 10/9/13 |
Celsius, Celsius RMT, EZ Steer Non-Temp Sensing Ablation Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of an alternate supplier for the extrusion and braiding process for the family of products. |
P950020/S065 10/18/13 |
Coronary Flextome® Cutting Balloon® | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P950024/S051 10/10/10 |
CapSure Epicardial Pacing Lead | Medtronic CRDM Mounds View, MN 55112 |
Implementation of an automatic visual inspection system for labels received at incoming inspection. |
P950024/S052 10/17/13 |
CapSure Epicardial Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery products. |
P950029/S084 10/2/13 |
Reply SR, Reply DR, Esprit SR, Esprit,DR | Sorin CRM USA Inc. Arvada, CO 80004 |
Change to the routine bioburden monitoring before sterilization. |
P960009/S179 10/3/13 |
DBS Extensions; DBS Leads |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Updates to the current Final Pack Label Printing Equipment Controller, which is used during the sterile final package operation at Medtronic Puerto Rico Operations Company (MPROC) in Villalba, Puerto Rico. |
P960009/S180 10/10/13 |
Activa SC INS, Scletro INS, Kinetra INS and Pocket Adaptors | Medtronic Neuromodulation Minneapolis, MN 55432 |
New materials for the integrated circuit component. |
P960009/S181 10/23/13 |
DBS Programming Systems N’Vision Programmer, DBS Programming Systems Access Therapy Controller, DBS Programming Systems Access Review Therapy Controller |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Qualification of an alternate supplier for a critical device component. |
P960009/S182 10/22/13 |
7428 Kinetra® INS, 37601Activa® PC INS, 37602 Activa SC INS, 37603 Activa SC INS, 37612 Activa RC INS | Medtronic Neuromodulation Minneapolis, MN 55432 |
Increase the use before date storage shelf life of the Tyvek lid packaging component used in the sterile packaging configuration of multiple implantable neuromodulation products. |
P960009/S183 10/10/13 |
Soletra® INS-7426, Kinetra® INS 7428, Activa® PC -37601 Activa SC INS 37602, & 37603, and Activa RC INS | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use of SAP Enterprise Central Component 6 Enhancement Pack 5 at Medtronic Puerto Rico Operations Company, Juncos, and Puerto Rico. |
P960009/S184 10/30/13 |
37601 Activa® PC INS, 37612 Activa RC INS, 37022 External Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of a new header subassembly laser weld station. |
P960013/S076 10/2/13 |
Tendril and OptiSense Pacemaker Lead Families | St. Jude Medical Sylmar, CA 91342 |
Implementation of an Automated Lead Tester (ALT) during manufacturing of the lead families. |
P960030/S038 10/2/13 |
IsoFlex pacemaker Lead Families | St. Jude Medical Sylmar, CA 91342 |
Implementation of an Automated Lead Tester (ALT) during manufacturing of the lead families. |
P970004/S158 10/3/13 |
SNS Urinary Extensions; SNS Urinary Leads |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Updates to the current Final Pack Label Printing Equipment Controller, which is used during the sterile final package operation at Medtronic Puerto Rico Operations Company (MPROC) in Villalba, Puerto Rico. |
P970004/S159 10/10/13 |
Interstim Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
New materials for the integrated circuit component. |
P970004/S160 10/23/13 |
SNS Urinary Programming Systems N’Vision Programmer | Medtronic Neuromodulation Minneapolis, MN 55432 |
Qualification of an alternate supplier for a critical device component. |
P970004/S161 10/22/13 |
InterStim II INS | Medtronic Neuromodulation Minneapolis, MN 55432 |
Increase the use before date storage shelf life of the Tyvek lid packaging component used in the sterile packaging configuration of multiple implantable neuromodulation products. |
P970004/S162 10/10/13 |
Interstim Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use of SAP Enterprise Central Component 6 Enhancement Pack 5 at Medtronic Puerto Rico Operations Company, Juncos, and Puerto Rico. |
P970004/S163 10/30/13 |
SNS Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of a new header subassembly laser weld station. |
P970031/S044 10/17/13 |
Freestyle Aortic Root Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
New Single Pass Flow machine used to estimate the effective orifice area of the bioprosthetic heart valves. |
P980003/S042 10/18/13 |
Chilli II Cooled Ablation Catheter and Cable | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to implement the Central Monitoring System (CMS) at the sterilization facility. |
P980003/S043 10/23/13 |
Chilli II Cooled Ablation Catheter | Boston Scientific Corporation Maple Grove, MN 55311 |
Change in the quality control (QC) inspections of the cardiac ablation system cables. |
P980016/S438 10/2/13 |
Evera ICDs | Medtronic, Inc. Mounds View MN, 55112 |
Software updates to the laser weld process for the capacitors used in the Viva, Brava, and Evera Family of devices. |
P980016/S439 10/10/13 |
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 |
Update to the Sonoscan acceptance criteria inspection process. |
P980016/S440 10/10/13 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Two new rework processes for the devices. |
P980016/S442 10/23/13 |
Evera S DR/VR, Evera XT DR/VR, Maximo II, Protecta, Protecta XT, Secura, Virtuoso II DR/VR ICDs |
Medtronic, Inc. Mounds View, MN 55112 |
Use of a new Enterprise system for various business processes. |
P980033/S037 10/18/13 |
WALLSTENT® (Venous) Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P980035/S345 10/10/13 |
ADVISA, ADVISA MRI | Medtronic CRDM Mounds View, MN 55112 |
Addition of a duplicate battery electrolyte fill station. |
P980035/S346 10/10/13 |
Adapta, Versa, Sensia IPG and Relia IPG |
Medtronic CRDM Mounds View, MN 55112 |
Change to the current battery burn-in test system processing, inspection methods, and associated software. |
P980035/S347 10/23/13 |
Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new Enterprise system for various business processes. |
P980035/S348 10/25/13 |
Adapta, Versa, Sensia Implantable Pulse Generator IPGs and Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Supplier site location transfer and process changes for an accelerometer crystal used in Models ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, ADSR01, ADSR03, ADSR06, ADVDD01, SED01, SEDR01, SEDRL1, SES01, SESR01, and VEDR01 and Relia IPG Models RED01, REDR01, RES01, RESR01, and REVDD01 |
P980043/S044 10/17/13 |
Hancock II Bioprosthetic Heart Valve | Medtronic Heart Valves Santa Ana, CA 92705 |
New Single Pass Flow machine used to estimate the effective orifice area of the bioprosthetic heart valves. |
P980049/S087 10/2/13 |
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR, Isoline 2CT, Isoline 2CR |
Sorin CRM USA Inc. Arvada, CO 80004 |
Change to the routine bioburden monitoring before sterilization. |
P980049/S088 10/29/13 |
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR | Sorin CRM USA Inc. Arvada, CO 80004 |
Addition of alternative laser welding equipment and a modification to the laser weld program. |
P980050/S085 10/17/13 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery products. |
P990046/S036 10/9/13 |
Open Pivot Heart Valve | Medtronic, Inc. Minneapolis, MN 55432 |
New piece of equipment intended for automated inspection of the mechanical valve subassembly. |
P990064/S052 10/17/13 |
Mosaic Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
New Single Pass Flow machine used to estimate the effective orifice area of the bioprosthetic heart valves. |
P990081/S022 10/2/13 |
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Add a supplier (Roche, Penzberg) of a component (Streptavidin Horseradish Peroxidase) for the iVIEW DAB Detection kit. |
P000007/S043 10/11/13 |
Edwards Prima Plus Stentless Porcine Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of a new sterile wiper for use in cleanrooms and non-controlled environments to clean work surfaces and tools. |
P000012/S045 10/9/13 |
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/COBAS® AMPLICOR® HCV Test version 2.0 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change for the addition of a new supplier of sub-assemblies used in the production of the instrument for the devices. |
P000012/S046 10/9/13 |
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/COBAS® AMPLICOR® HCV Test version 2.0 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change for the addition of a new supplier of sub-assemblies used in the production of the instrument for the devices. |
P010013/S049 10/10/13 |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Installation of new equipment used in the testing of the NovaSure RF Controller units. |
P010014/S046 10/17/13 |
Oxford Meniscal Unicompartmental Knee System | Biomet Manufacturing Corporation Warsaw, IN 4682 |
Change to use a different mold release agent in the manufacturing of the bearing components of Biomet’s Oxford Partial Knee System. |
P010015/S218 10/10/13 |
CONSULTA, SYNCRA | Medtronic CRDM Mounds View, MN 55112 |
Addition of a duplicate battery electrolyte fill station. |
P010015/S219 10/10/13 |
Attain Bipolar OTW Lead, Left Ventricular Pacing Lead | Medtronic CRDM Mounds View, MN 55112 |
Implementation of an automatic visual inspection system for labels received at incoming inspection. |
P010015/S220 10/17/13 |
Consulta CRT-P, Syncra CRT-P |
Medtronic, Inc. Mounds View, MN 55112 |
Alternate supplier for molded silicone desiccant components. |
P010015/S221 10/23/13 |
Consulta, Syncra CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new Enterprise system for various business processes. |
P010015/S222 10/17/13 |
Attain Bipolar OTW Lead, Left Ventricular Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery products. |
P010030/S044 10/3/13 |
Lifevest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Four manufacturing changes related to the LifeVest 4000 Auto Test Fixture used to automate the functionality testing of the device. |
P010031/S399 10/2/13 |
Viva/Brava CRT-Ds | Medtronic, Inc. Mounds View MN, 55112 |
Software updates to the laser weld process for the capacitors used in the Viva, Brava, and Evera Family of devices. |
P010031/S400 10/10/13 |
Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Update to the Sonoscan acceptance criteria inspection process. |
P010031/S401 10/10/13 |
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Two new rework processes for the devices. |
P010031/S403 10/23/13 |
Brava, Concerto II, Consulta, Maximo II, Protecta, Protecta XT, Viva S, Viva XT CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Use of a new Enterprise system for various business processes. |
P010041/S045 10/11/13 |
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of a new sterile wiper for use in cleanrooms and non-controlled environments to clean work surfaces and tools. |
P020004/S087 10/8/13 |
Gore EXCLUDER AAA Endoprosthesis | W.L. Gore & Associates, Inc. Phoenix, AZ 85085 |
Duplication of the current combined SIM-PULL and C3 catheter manufacturing process; addition of a new ISO 8 cleanroom at an already approved facility; and machinery and recipes upgrades at both approved manufacturing facilities. |
P020009/S110 10/18/13 |
Express 2 Monorail and Over-the-Wire | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to implement the Central Monitoring System (CMS) at the sterilization facility. |
P020009/S111 10/18/13 |
Express 2 Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P020025/S047 10/18/13 |
Blazer II XP Cardiac Ablation Catheter and Cable | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to implement the Central Monitoring System (CMS) at the sterilization facility. |
P020025/S048 10/23/13 |
Blazer IIXP/Blazer Prime XP Ablation Catheters and EPT-1000 XP Cardiac Ablation Controller | Boston Scientific Corporation Maple Grove, MN 55311 |
Change in the quality control (QC) inspections of the cardiac ablation system cables. |
P020030/S010 10/2/13 |
Stelid BTF/BJF | Sorin CRM USA Inc. Arvada, CO 80004 |
Change to the routine bioburden monitoring before sterilization. |
P020047/S054 10/4/13 |
MULTI-LINK 8 Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Change to the stent dislodgement testing sampling plan. |
P020047/S055 10/28/13 |
MULTI-LINK 8 Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Change to the sampling plan used for pyrogen testing at the Temecula, California, manufacturing facility. |
P020055/S009 10/2/13 |
PATHWAY Anti-c-KIT (9.7) Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Add a supplier (Roche, Penzberg) of a component (Streptavidin Horseradish Peroxidase) for the iVIEW DAB Detection kit. |
P030004/S008 10/9/13 |
Onyx Liquid Embolic System | Micro Therapeutics, Inc. DBA Ev3 Neurovascular Irvine, CA 92618 |
Add an alternate supplier for pyrogen testing. |
P030005/S103 10/10/13 |
INVIVE, INTUA Cardiac Resynchronization Therapy Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of new cleaners and cleaning solution for the Pulse Generator (PG) feedthru assembly process. |
P030009/S068 10/24/13 |
Integrity RX and OTW Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Changes to the Vision Assist Precision Welder including the addition of a new motor, replacement of the chuck/collet fixture, removal of the scan by the overhead camera, and updated software to ensure appropriate set-up is completed. |
P030009/S069 10/23/13 |
Integrity Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Modification of the stress test for the over-the-wire (OTW) luer conducted by the supplier. |
P030022/S026 10/25/13 |
Reflection Ceramic Acetabular Hip System | Smith & Nephew Incorporated Memphis, TN 38116 |
Change to add a new rotary grit blaster. |
P030026/S028 10/17/13 |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator | Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 |
Change to the manufacturing process for streptavidin coated (SAC) wells included in the VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator. |
P030031/S057 10/9/13 |
Celsius ThermoCool, Celsius RMT ThermoCool Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of an alternate supplier for the extrusion and braiding process for the family of products. |
P030035/S113 10/2/13 |
Anthem CRT-Ps | St. Jude Medical Sylmar, CA 91342 |
Addition of a visual inspection during the assembly of the Accent and Anthem family of devices. |
P030036/S061 10/10/13 |
SelectSecure Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an ellipsometry inspection step for ETFE jacketed wire and cable components. |
P030036/S062 10/10/13 |
SelectSecure Lead | Medtronic CRDM Mounds View, MN 55112 |
Implementation of an automatic visual inspection system for labels received at incoming inspection. |
P030036/S063 10/25/13 |
SelectSecure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Minor changes to the plasma treatment process for a silicone tubing component used in the Model 3830 SelectSecure Lead. |
P030036/S064 10/17/13 |
SelectSecure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery products. |
P040016/S116 10/18/13 |
VeriFLEX (Liberté) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to implement the Central Monitoring System (CMS) at the sterilization facility. |
P040016/S117 10/18/13 |
VeriFLEX™ (Liberté®) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P040024/S071 10/25/13 |
Restylane/Perlane/ Restylane-L/ Perlane-L Injectable Gels | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 |
In-house prepared acidic and basic solutions, as well as in-house prepared water for injection. |
P040027/S032 10/4/13 |
GORE VIATORR TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Use of an alternate polytetrafluoro-ethylene (PTFE) resin raw material and an alternate manufacturing aid during the overwrap process. |
P040036/S040 10/9/13 |
Navistar-, Navistar RMT-, EZ Steer- ThermoCool Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of an alternate supplier for the extrusion and braiding process for the family of products. |
P040037/S055 10/4/13 |
GORE VIABAHN Endoprosthesis and VIABAHN with Heparin Bioactive Surface | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Use of an alternate polytetrafluoro-ethylene (PTFE) resin raw material and an alternate manufacturing aid during the overwrap process. |
P040037/S056 10/16/13 |
GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Clarification to an inspection acceptance criterion for the assembled prosthesis and delivery system. |
P040037/S057 10/17/13 |
GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Addition of new manufacturing equipment which will automate the removal of the VIABAHN device graft component from the processing mandrel. |
P040038/S030 10/28/13 |
Xact Carotid Stent System | Abbott Vascular Temecula, CA 92591 |
Change to the sampling plan used for pyrogen testing at the Temecula, California, manufacturing facility. |
P040043/S057 10/25/13 |
Gore TAG Endoprosthesis | W. L. Gore & Associates Flagstaff, AZ 86001 |
Modify the surface treatment of the Nitinol stent component. |
P040047/S028 10/24/13 |
Coaptite Injectable Implant | Merz North America, Inc. Franksville, WI 53126 |
Change to the bioburden testing. |
P040047/S029 10/24/13 |
Coaptite Injectable Implant | Merz North America, Inc. Franksville, WI 53126 |
Change in the sterilization racks. |
P050019/S018 10/18/13 |
Carotid WALLSTENT® Monorail® Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P050019/S019 10/23/13 |
Carotid WALLSTENT® Monorail® Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an alternate vendor for the tackifier resin used in the product packaging adhesive. |
P050028/S036 10/9/13 |
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/COBAS® TaqMan® HBV Test version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change for the addition of a new supplier of sub-assemblies used in the production of the instrument for the devices. |
P050028/S037 10/9/13 |
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change for the addition of a new supplier of sub-assemblies used in the production of the instrument for the devices. |
P050037/S041 10/24/13 |
Radiesse Injectable Implant | Merz North America, Inc. Franksville, WI 53126 |
Changes to Bioburden Testing. |
P050051/S022 10/18/13 |
ARCHITECT AUSAB | Abbott Laboratories Diagnostics Abbott Park, IL 60064 |
Change to add alternate suppliers for the incoming positive human plasma. |
P050052/S044 10/24/13 |
Radiesse Injectable Implant | Merz North America, Inc. Franksville, WI 53126 |
Changes to Bioburden Testing. |
P060006/S049 10/18/13 |
Express SD Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to implement the Central Monitoring System (CMS) at the sterilization facility. |
P060006/S050 10/18/13 |
Express™ SD Renal Monorail™ Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P060027/S055 10/2/13 |
Paradym CRT-D, Paradym RF CRT-D, Situs OTW UW28D | Sorin CRM USA Inc. Arvada, CO 80004 |
Change to the routine bioburden monitoring before sterilization. |
P060027/S056 10/29/13 |
Paradym CRT-D, Paradym RF CRT-D | Sorin CRM USA Inc. Arvada, CO 80004 |
Addition of alternative laser welding equipment and a modification to the laser weld program. |
P060030/S036 10/9/13 |
COBAS® AmpliPrep/COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test Version 2.0 For Use With The High Pure System | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change for the addition of a new supplier of sub-assemblies used in the production of the instrument for the devices. |
P060030/S037 10/9/13 |
COBAS® AmpliPrep/COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change for the addition of a new supplier of sub-assemblies used in the production of the instrument for the devices. |
P060033/S081 10/24/13 |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Addition of optical sensors to the glass scale of the flow meter at the specification limits to assist the operator in accepting/ rejecting the hypotube under inspection. |
P060033/S082 10/23/13 |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Modification of the stress test for the over-the-wire (OTW) luer conducted by the supplier. |
P060039/S050 10/10/13 |
Attain StarFix Lead | Medtronic CRDM Mounds View, MN 55112 |
Implementation of an automatic visual inspection system for labels received at incoming inspection. |
P060039/S051 10/17/13 |
Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery products. |
P070015/S114 10/28/13 |
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 |
Change to the sampling plan used for pyrogen testing at the Temecula, California, manufacturing facility. |
P080006/S058 10/17/13 |
Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing and inspection process for tubing used in Medtronic CRDM Therapy Delivery products. |
P080020/S006 10/11/13 |
Gel-One | Seikagaku Corporation Tokyo, Japan 100-0005 |
Manufacturing location changes within the current facilities. |
P080025/S054 10/3/13 |
SNS Bowel Extensions; SNS Bowel Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Updates to the current Final Pack Label Printing Equipment Controller, which is used during the sterile final package operation at Medtronic Puerto Rico Operations Company (MPROC) in Villalba, Puerto Rico. |
P080025/S055 10/10/13 |
Interstim Therapy for Bowel Control | Medtronic Neuromodulation Minneapolis, MN 55432 |
New materials for the integrated circuit component. |
P080025/S056 10/23/13 |
SNS Bowel Programming Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Qualification of an alternate supplier for a critical device component. |
P080025/S057 10/22/13 |
SNS Bowle Accessories, SNS Bowel Extension, SNS Bowel Leads, SNS Bowel Neurostimulators Implantable InterStim Family, SNS Bowel Screening Trialing System (including Temporary Leads) | Medtronic Neuromodulation Minneapolis, MN 55432 |
Increase the use before date storage shelf life of the Tyvek lid packaging component used in the sterile packaging configuration of multiple implantable neuromodulation products. |
P080025/S058 10/10/13 |
Interstim Therapy for Bowel Control | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use of SAP Enterprise Central Component 6 Enhancement Pack 5 at Medtronic Puerto Rico Operations Company, Juncos, and Puerto Rico. |
P080025/S059 10/30/13 |
SNS Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of a new header subassembly laser weld station. |
P080027/S014 10/3/13 |
OraQuick® HCV Rapid Antibody Test | OraSure Technologies, Inc. Bethlehem, PA 18015 |
Change to an incoming raw material specification. |
P090003/S028 10/18/13 |
Express® LD Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P090006/S011 10/17/13 |
Complete SE Vascular Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Modify the bonding process for the stability member subcomponent of the delivery system. |
P090013/S113 10/10/13 |
REVO MRI | Medtronic CRDM Mounds View, MN 55112 |
Addition of a duplicate battery electrolyte fill station. |
P090013/S114 10/10/13 |
CapSureFix MRI Lead | Medtronic CRDM Mounds View, MN 55112 |
Implementation of an automatic visual inspection system for labels received at incoming inspection. |
P090013/S115 10/23/13 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new Enterprise system for various business processes. |
P090028/S007 10/17/13 |
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator | Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 |
Change to the manufacturing process for streptavidin coated (SAC) wells included in the VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator. |
P100001/S006 10/17/13 |
VITROS Immunodiagnostics Products Anti-HBe Reagent Pack and Calibrator | Ortho Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
Change to the manufacturing process for streptavidin coated (SAC) wells included in the VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator. |
P100021/S029 10/25/13 |
Endurant Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Change the sampling for the Limulus Amebocyte Lysate (LAL) bacterial endotoxin testing. |
P100022/S009 10/16/13 |
Zilver PTX Drug-Eluting Peripheral Stent | Cook Inc. Bloomington, IN 47402 |
Modify the handle assembly and pusher cannula/holding bushing bonding processes for the Zilver PTX Drug-Eluting Peripheral Stents. |
P100023/S078 10/18/13 |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to implement the Central Monitoring System (CMS) at the sterilization facility. |
P100023/S079 10/18/13 |
ION™ (Taxus® Element™) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P100027/S011 10/10/13 |
INFORM HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Addition of a new supplier of two bioconjugates for the ultraView SISH DNP Detection kit and theultraView Red ISH DIG Detection kit. Both detection kits are parts of the INFORM HER2 Dual ISH DNA Probe Cocktail. |
P100041/S040 10/11/13 |
Edwards SAPIEN Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of a new sterile wiper for use in cleanrooms and non-controlled environments to clean work surfaces and tools. |
P100047/S030 10/17/13 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Outsource the manufacture of the sewing ring component of the device. |
P100047/S031 10/30/13 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Modification of the in-process visual inspection and addition of a variable inspection method for two device components which are part of the HeartWare® Ventricular Assist System. |
P110010/S061 10/18/13 |
PROMUS Element Plus Everolimus-Eluting Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to implement the Central Monitoring System (CMS) at the sterilization facility. |
P110010/S062 10/18/13 |
PROMUS® Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P110013/S026 10/24/13 |
Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Changes to the Vision Assist Precision Welder including the addition of a new motor, replacement of the chuck/collet fixture, removal of the scan by the overhead camera, and updated software to ensure appropriate set-up is completed. |
P110013/S027 10/23/13 |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Modification of the stress test for the over-the-wire (OTW) luer conducted by the supplier. |
P110019/S054 10/28/13 |
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems and XIENCE Xpedition Everolimus Eluting Coronary Stent Systems (EECSS) | Abbott Vascular Temecula, CA 92591 |
Change to the sampling plan used for pyrogen testing at the Temecula, California, manufacturing facility. |
P110021/S027 10/11/13 |
Edwards SAPIEN Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of a new sterile wiper for use in cleanrooms and non-controlled environments to clean work surfaces and tools. |
P110029/S013 10/18/13 |
ARCHITECT HBsAg Qualitative Confirmatory | Abbott Laboratories Diagnostics Abbott Park, IL 60064 |
Change to add alternate suppliers for the incoming positive human plasma. |
P110035/S020 10/18/13 |
EPIC Vascular Self-Expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to implement the Central Monitoring System (CMS) at the sterilization facility. |
P110035/S021 10/18/13 |
Epic™ Vascular Self-Expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software changes to update the manufacturing execution system. |
P110035/S022 10/24/13 |
Epic™ Vascular Self-Expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Implementation of a process change for stretching and necking a PTFE tube used in the manufacture of the delivery system. |
P110037/S010 10/9/13 |
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change for the addition of a new supplier of sub-assemblies used in the production of the instrument for the devices. |
P110037/S011 10/9/13 |
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change for the addition of a new supplier of sub-assemblies used in the production of the instrument for the devices. |
P120005/S012 10/17/13 |
Dexcom G4 PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Manufacturing process change to standardize the visual inspection of G4 PLATINUM sensor/applicator packaging prior to sterilization. |