Medical Devices

October 2013 PMA Approvals

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE 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™ XCAllergan
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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P830055/S139
10/29/13
Special
LCS® Total Knee SystemDePuy 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 SystemsBeckman 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 SystemsBeckman 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 AdapterThoratec 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 MonitorMedtronic, 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 MonitorMedtronic, 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 SystemBoston 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 ControlMedtronic 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™ SystemBD 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 SystemsBeckman 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 SystemsBeckman 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 SystemCochlear 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 ImplantCochlear 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 SystemBoston 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'sMedtronic, 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 VRMedtronic, 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 MarquisMedtronic, 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 XTMedtronic, 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 VRMedtronic, 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 MRIMedtronic, 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 SystemsBeckman 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 SystemsBeckman 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 ImplantsMentor 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 SystemVentana 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 GELSalix 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-PMedtronic, 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’sMedtronic, 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-DMedtronic, 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 ProtectaMedtronic, 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 XTMedtronic, 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-DMedtronic, 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 SystemSt. 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 ControlBayer 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 SystemBoston 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 IIAlcon 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 SystemAlcon 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 SurfaceW.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 RTStryker 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 BioprosthesisMedtronic 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 SystemMedtronic 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 ComponentsDePuy 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 SystemDePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Addition of a tamp extractor instrument.
P080025/S051
10/22/13
180-Day
InterStim Therapy for Bowel ControlMedtronic 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 HBVAbbott 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 m2000sp instrument; and 3) Associated software revisions.
P090013/S110
10/15/13
Real-Time
Revo MRIMedtronic, 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 SystemBeckman 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 SystemBeckman 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 DeviceMicro 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 StentCook 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 SystemMedtronic 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 SystemCameron 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N970003/S156
10/10/13
ADVANTIO, INGENIO, VITALIO, FORMIO PacemakersBoston 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 StimulatorsBiomet 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+ LeadMedtronic 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+ LeadMedtronic, 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 NeurostimulatorsMedtronic 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 NeurostimulatorsMedtronic 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 NeurostimulatorsMedtronic 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 NeurostimulatorsMedtronic Neuromodulation
Minneapolis, MN 55432
Implementation of a new header subassembly laser weld station.
P850035/S036
10/3/13
SpF Implantable Spinal Fusion StimulatorsBiomet 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 LeadMedtronic 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 LeadMedtronic, 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 PumpsMedtronic Neuromodulation
Minneapolis, MN 55432
New materials for the integrated circuit component.
P860004/S196
10/23/13
Drug Delivery Programming Systems N’Vision ProgrammerMedtronic Neuromodulation
Minneapolis, MN 55432
Qualification of an alternate supplier for a critical device component.
P860004/S197
10/22/13
Synchromed Drug Infusion System-Neuromodulation ProductsMedtronic 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 PumpsMedtronic 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 PumpMedtronic Neuromodulation
Minneapolis, MN 55432
Implementation of a new header subassembly laser weld station.
P860004/S200
10/28/13
SynchroMed II Implantable Infusion PumpMedtronic Neuromodulation
Minneapolis, MN 55432
SynchroMed II battery burn-in process be updated.
P860057/S113
10/11/13
Carpentier-Edwards Perimount Pericardial BioprosthesisEdwards 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 BioprosthesisEdwards 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 MitralEdwards 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 ConduitMedtronic, 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 PacemakersSt. 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 IPGMedtronic 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 LeadMedtronic CRDM
Mounds View, MN 55112
Implementation of an automatic visual inspection system for labels received at incoming inspection.
P890003/S288
10/17/13
CapSure LeadMedtronic, 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 SystemBoston Scientific Corporation
Maple Grove, MN 55311
Software changes to update the manufacturing execution system.
P910001/S067
10/2/13
Spectranetics CVX-300 Excimer Laser SystemsSpectranetics Corporation
Colorado Springs, CO
80921
Supplier change for the printed circuit board assemblies.
P920015/S118
10/10/13
Sprint Quattro LeadMedtronic 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 LeadsMedtronic, 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 LeadMedtronic, 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 LEADSMedtronic, 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 CableBoston 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 CathetersBoston 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) EndoprosthesisBoston 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 LeadMedtronic 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 LeadMedtronic, 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) EndoprosthesisBoston 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 CathetersBiosense 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 LeadMedtronic 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 LeadMedtronic, 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,DRSorin 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 AdaptorsMedtronic 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 INSMedtronic 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 INSMedtronic 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 NeurostimulatorMedtronic Neuromodulation
Minneapolis, MN 55432
Implementation of a new header subassembly laser weld station.
P960013/S076
10/2/13
Tendril and OptiSense Pacemaker Lead FamiliesSt. 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 FamiliesSt. 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 NeurostimulatorsMedtronic Neuromodulation
Minneapolis, MN 55432
New materials for the integrated circuit component.
P970004/S160
10/23/13
SNS Urinary Programming Systems N’Vision ProgrammerMedtronic Neuromodulation
Minneapolis, MN 55432
Qualification of an alternate supplier for a critical device component.
P970004/S161
10/22/13
InterStim II INSMedtronic 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 NeurostimulatorsMedtronic 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 NeurostimulatorsMedtronic Neuromodulation
Minneapolis, MN 55432
Implementation of a new header subassembly laser weld station.
P970031/S044
10/17/13
Freestyle Aortic Root BioprosthesisMedtronic 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 CableBoston 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 CatheterBoston 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 ICDsMedtronic, 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 ICDMedtronic, 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) EndoprosthesisBoston Scientific Corporation
Maple Grove, MN 55311
Software changes to update the manufacturing execution system.
P980035/S345
10/10/13
ADVISA, ADVISA MRIMedtronic 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 IPGsMedtronic, 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 IPGsMedtronic, 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 ValveMedtronic 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 DRSorin 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 LeadMedtronic, 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 ValveMedtronic, Inc.
Minneapolis, MN 55432
New piece of equipment intended for automated inspection of the mechanical valve subassembly.
P990064/S052
10/17/13
Mosaic Porcine BioprosthesisMedtronic 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 AntibodyVentana 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 BioprosthesisEdwards 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 SystemHologic, 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 SystemBiomet 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, SYNCRAMedtronic 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 LeadMedtronic 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-PsMedtronic, 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 LeadMedtronic, 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 DefibrillatorZoll 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-DsMedtronic, 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-DMedtronic, 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 BioprosthesisEdwards 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 EndoprosthesisW.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-WireBoston 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 SystemBoston 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 CableBoston 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 ControllerBoston 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/BJFSorin CRM USA Inc.
Arvada, CO
80004
Change to the routine bioburden monitoring before sterilization.
P020047/S054
10/4/13
MULTI-LINK 8 Coronary Stent SystemAbbott Vascular
Temecula, CA 92591
Change to the stent dislodgement testing sampling plan.
P020047/S055
10/28/13
MULTI-LINK 8 Coronary Stent SystemAbbott 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 AntibodyVentana 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 SystemMicro 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 PacemakersBoston 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 SystemMedtronic 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 SystemsMedtronic 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 SystemSmith & 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 CalibratorOrtho 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 CathetersBiosense 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-PsSt. 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 LeadMedtronic, Inc.
Mounds View, MN 55112
Addition of an ellipsometry inspection step for ETFE jacketed wire and cable components.
P030036/S062
10/10/13
SelectSecure LeadMedtronic CRDM
Mounds View, MN 55112
Implementation of an automatic visual inspection system for labels received at incoming inspection.
P030036/S063
10/25/13
SelectSecure LeadMedtronic, 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 LeadMedtronic, 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 SystemBoston 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 SystemBoston 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 GelsMedicis 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 EndoprosthesisW.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 CathetersBiosense 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 SurfaceW.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 SurfaceW.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 HeparinW.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 SystemAbbott 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 EndoprosthesisW. L. Gore & Associates
Flagstaff, AZ
86001
Modify the surface treatment of the Nitinol stent component.
P040047/S028
10/24/13
Coaptite Injectable ImplantMerz North America, Inc.
Franksville, WI 53126
Change to the bioburden testing.
P040047/S029
10/24/13
Coaptite Injectable ImplantMerz North America, Inc.
Franksville, WI 53126
Change in the sterilization racks.
P050019/S018
10/18/13
Carotid WALLSTENT® Monorail® EndoprosthesisBoston Scientific Corporation
Maple Grove, MN 55311
Software changes to update the manufacturing execution system.
P050019/S019
10/23/13
Carotid WALLSTENT® Monorail® EndoprosthesisBoston 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 2.0Roche 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 ImplantMerz North America, Inc.
Franksville, WI 53126
Changes to Bioburden Testing.
P050051/S022
10/18/13
ARCHITECT AUSABAbbott Laboratories
Diagnostics
Abbott Park, IL 60064
Change to add alternate suppliers for the incoming positive human plasma.
P050052/S044
10/24/13
Radiesse Injectable ImplantMerz North America, Inc.
Franksville, WI 53126
Changes to Bioburden Testing.
P060006/S049
10/18/13
Express SD Monorail Premounted Stent SystemBoston 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 SystemBoston 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 UW28DSorin 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-DSorin 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 SystemRoche 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 SystemRoche 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 SystemMedtronic 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 SystemMedtronic 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 LeadMedtronic 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 LeadMedtronic, 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 SystemsAbbott 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 LeadMedtronic, 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-OneSeikagaku Corporation
Tokyo, Japan
100-0005
Manufacturing location changes within the current facilities.
P080025/S054
10/3/13
SNS Bowel Extensions; SNS Bowel LeadsMedtronic 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 ControlMedtronic Neuromodulation
Minneapolis, MN 55432
New materials for the integrated circuit component.
P080025/S056
10/23/13
SNS Bowel Programming SystemsMedtronic 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 ControlMedtronic 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 NeurostimulatorsMedtronic Neuromodulation
Minneapolis, MN 55432
Implementation of a new header subassembly laser weld station.
P080027/S014
10/3/13
OraQuick® HCV Rapid Antibody TestOraSure Technologies, Inc.
Bethlehem, PA 18015
Change to an incoming raw material specification.
P090003/S028
10/18/13
Express® LD Iliac Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Software changes to update the manufacturing execution system.
P090006/S011
10/17/13
Complete SE Vascular Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Modify the bonding process for the stability member subcomponent of the delivery system.
P090013/S113
10/10/13
REVO MRIMedtronic CRDM
Mounds View, MN 55112
Addition of a duplicate battery electrolyte fill station.
P090013/S114
10/10/13
CapSureFix MRI LeadMedtronic 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 IPGMedtronic, 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 CalibratorOrtho 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 CalibratorOrtho 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 SystemMedtronic 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 StentCook 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 SystemBoston 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 SystemBoston 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 CocktailVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier of two bioconjugates for the ultraView SISH DNP Detection kit and the ultraView 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 AccessoriesEdwards 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 SystemHeartWare, Inc.
Miami Lakes, FL 33014
Outsource the manufacture of the sewing ring component of the device.
P100047/S031
10/30/13
HeartWare® Ventricular Assist SystemHeartWare, 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 SystemBoston 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 SystemBoston 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 SystemMedtronic 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 SystemMedtronic 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 AccessoriesEdwards 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 ConfirmatoryAbbott 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 SystemBoston 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 SystemBoston Scientific Corporation
Maple Grove, MN 55311
Software changes to update the manufacturing execution system.
P110035/S022
10/24/13
Epic™ Vascular Self-Expanding Stent SystemBoston 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 SystemDexcom, Inc.
San Diego, CA 92121
Manufacturing process change to standardize the visual inspection of G4 PLATINUM sensor/applicator packaging prior to sterilization.

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

Page Last Updated: 06/17/2014
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