Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 78
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 30
Total On Hold: 27
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 581
Total Active: 443
Total On Hold: 138
Number Greater Than 180 Days: 5
Summary of All PMA Submissions Received
Originals: 0
Supplements: 57
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 78
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 145.7
FDA Time: 104.9 Days MFR Time: 40.8 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P100003 9/28/12 |
Secure-C Artificial Cervical Disc | Globus Medical, Inc. Audubon, PA 19403 |
Approval for the Secure-C Artificial Cervical Disc. This device is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single- level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The SECURE®-C Cervical Artificial Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the SECURE®-C Cervical Artificial Disc. |
| P110006 9/18/12 |
somo-v® Automated Breast Ultrasound System (ABUS) | U-Systems, Inc. Sunnyvale, CA 94085 |
Approval for the somo-v®: Automated Breast Ultrasound System (ABUS). This device is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening mammography findings are normal or benign (BI-RADS Assessment Category 1 or 2), with dense breast parenchyma (BI-RADS Composition/ Density 3 or 4) and have not had previous clinical breast intervention. The device is intended to increase breast cancer detection in the described patient population. |
| P110038 9/21/12 |
Relay® Thoracic Stent-Graft with Plus Delivery System | Bolton Medical, Inc. Sunrise, FL 33325 |
Approval for the Relay® Thoracic Stent-Graft with Plus Delivery System. This device is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/ penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including: 1) Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices and/or accessories; 2) Non-aneurysmal aortic neck diameter in the range of 19 – 42 mm; and 3) Non-aneurysmal proximal aortic neck lengths between 15 and 25 nun and distal aortic neck lengths between 25 and 30 mm depending on the diameter stent-graft required |
| P110042 9/28/12 |
Subcutaneous Implantable Defibrillator (S-ICD®) System | Cameron Health, Inc. San Clemente, CA 92673 |
Approval for the Subcutaneous Implantable Defibrillator (S-ICD®) System. This device is indicated to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with antitachycardia pacing. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P840001/S199 9/6/12 180-Day |
Medtronic Implantable Neurostimulators for Spinal Cord Stimulation | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for a manufacturing site located at Medtronic Neuromodulation in Minneapolis, Minnesota. |
| P840001/S221 9/14/12 Real-Time |
Spinal Cord Stimulation Extension | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for minor modifications to the package dimensions, the inner tray and the retainer lid. Also requested was a package material change from Polyvinyl Chloride (PVC) to Polyethylene Terephthalate Glycol (PETG) for the outer tray, the inner tray and the retainer lid. |
| P880086/S221 9/6/12 Real-Time |
Affinity/Integrity/ Victory/Zephyr/ Accent Family of Pacemakers | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Approval for an update to the pace and sense integrated circuit. |
| P890003/S251 9/12/12 180-Day |
DDMA Software | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the use of recently approved software 9995 version 7.4 and associated DDMA software 2491 with recently approved device models D264VRM and D204VRM. |
| P890003/S258 9/25/12 Real-Time |
CareLink Monitor, CardioSight Reader Monitor, CareLink Express Monitor |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor. |
| P900060/S049 9/10/12 135-Day |
Carbomedics Prosthetic Heart Valve | Sorin Group USA, Inc. Arvada, CO 80004 |
Approval to add equipment to the Pyrolytic Carbon Coating Process. |
| P910023/S298 9/6/12 180-Day |
Ellipse DR, Ellipse VR, Fortify Assura DR and Fortify Assura VR ICDs | St. Jude Medical Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Operations Malaysia (SJM-MYPE) in Penang, Malaysia. |
| P910056/S011 9/4/12 Real-Time |
enVista® Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. Aliso Viejo, VA 92656 |
Approval for changes to the directions for use (DFU) to specify that the enVista MX60 lens is approved for use with the Medicel Accuject 2.6 injector set, or other injector sets that specifically identify the enVista MX60 lens in the cleared labeling. |
| P910077/S123 9/25/12 Real-Time |
LATITUDE PATIENT MANAGEMENT SYSTEM Application Server Software v7.03.0 1 on LATITUDE System Server | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the LATITUDE PATIENT MANAGEMENT SYSTEM Application Server Software v7.03.0 1 on LATITUDE System Server (Model 6488). |
| P950022/S079 9/13/12 180-Day |
Durata Leads | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for design changes to the helix-shaft subassembly of market approved Tendril Models 1882, 1888, 1988, 2088 and Durata Models 7120Q, 7121Q, 7122Q, 7120, 7121, 7122, 7130, and 7131 leads for improved manufacturability and cost. |
| P950037/S111 9/24/12 Real-Time |
Reocor S/D External Pacemaker | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for a change to the low impedance alarm and other minor changes. |
| P960013/S068 9/13/12 180-Day |
Tendril Leads | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for design changes to the helix-shaft subassembly of market approved Tendril Models 1882, 1888, 1988, 2088 and Durata Models 7120Q, 7121Q, 7122Q, 7120, 7121, 7122, 7130, and 7131 leads for improved manufacturability and cost. |
| P960016/S039 9/10/12 Real-Time |
Safire™ Cardiac Ablation System Catheter | St. Jude Medical Minnetonka, MN 55345 |
Approval for minor design modifications to the pinion gear component. |
| P970029/S021 9/13/12 Special |
TMR2000 Holmium Laser System | Cardiogenesis Kennesaw, GA 30144 |
Approval for changes to the instructions for use to clarify the device description, warnings, adverse effects and device operating instructions. |
| P970054/S009 9/5/12 180-Day |
Biotrin International’s Parvovirus B19 IgG Enzyme Immunoassay | Biotrin International, Ltd. Dublin, Ireland |
Approval for a manufacturing site located at Biotrin International LTD in Dublin, Ireland. |
| P970055/S010 9/5/12 180-Day |
Biotrin International’s Parvovirus B19 IgM Enzyme Immunoassay | Biotrin International, Ltd. Dublin, Ireland |
Approval for a manufacturing site located at Biotrin International LTD in Dublin, Ireland. |
| P970058/S025 9/21/12 180-Day |
ImageChecker M5000D | Hologic, Inc. Santa Clara, CA 95054 |
Approval for improvements in the CAD algorithm, updated digital test database and support for GE Senographe Essential FFDM. |
| P980016/S361 9/10/12 180-Day |
Protecta ICD; Protecta DF4 ICD; Protecta XT ICD; and Protecta XT DF4 ICD | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Protecta ICD Models D334DRG, D334VRG; Protecta DF4 ICD Models D334DRM, D334VRM; Protecta XT ICD Models D314DRG, D314VRG; Protecta XT DF4 ICD; Models D314DRM; and D314VRM. |
| P980016/S362 9/12/12 180-Day |
Application Software, Maximo II DF4 ICD, Secura DF4 ICD | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the use of recently approved software 9995 version 7.4 and associated DDMA software 2491 with recently approved device models D264VRM and D204VRM. |
| P980016/S381 9/25/12 Real-Time |
Entrust/Virtuoso/ Protecta, CareLink Monitor, Cardiosight Reader Monitor, CareLink Express Monitor |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor. |
| P980035/S290 9/25/12 Real-Time |
Enrythm, CardioSight Reader Monitor, CareLink Express Monitor | Medtronic, Inc. Mounds View, MN 55112 |
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor. |
| P980040/S035 9/12/12 180-Day |
TECNIS OptiBlue Intraocular Lens (IOL), and TECNIS OptiBlue 1-Piece IOL | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Approval for the addition of two additives (i.e., 2-(3’-t-butyl-2’-hydroxy-5’-vinyl-phenyl)-5-chlorobenzotriazole) (UVAM) and yellow dye) to the SENSAR soft acrylic IOLs (Models ZA9003 and ZCB00). |
| P000012/S036 9/18/12 135-Day |
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 |
Approval for the manufacturing changes to the DNA synthesizer instrument platform for the vialed master mix and probe reagent components. |
| P000023/S008 9/6/12 135-Day |
TMJ Fossa-Eminence and Condylar Prosthesis System | TMJ Medical Golden, CO 80401 |
Approval for changes in degreasing solvent, cutting/machine lubricants and packaging equipment. |
| P000035/S008 9/6/12 135-Day |
TMJ Fossa-Eminence Prosthesis System | TMJ Medical Golden, CO 80401 |
Approval for changes in degreasing solvent, cutting/machine lubricants and packaging equipment. |
| P000036/S011 9/5/12 135-Day |
Dermagraft | Advanced BioHealing, Inc. San Diego, CA 92121 |
Approval for the qualification of an alternate supplier for a critical device component. |
| P010015/S175 9/25/12 Real-Time |
InSync, Consulta and Syncra Family of IPGs, CardioSight Reader Monitor, CareLink Express Monitor | Medtronic, Inc. Mounds View, MN 55112 |
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor. |
| P010020/S024 9/4/12 180-Day |
AMS Acticon™ Neosphincter | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for modifications to the design specifications and manufacturing process of the AMS Acticon™ Control Pump, a component of the device. |
| P010031/S305 9/17/12 180-Day |
Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
Medtronic, Inc. Mounds View, MN 55112 |
Approval of the post-approval study protocol. |
| P010031/S314 9/10/12 180-Day |
Protecta CRT-D; Protecta DF4 CRT-D; Protecta XT CRT-D; Protecta XT DF4 CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for Protecta CRT-D Model D334TRG; Protecta DF4 CRT-D; Model 334TRM: Protecta XT CRT-D Model D314TRG; and Protecta XT DF4 CRT-D Model D314TRM. |
| P010031/S334 9/25/12 Real-Time |
Concerto/Protecta, CareLink Monitor, CardioSight Reader Monitor, CareLink Express Monitor |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor. |
| P010032/S058 9/14/12 Real-Time |
Eon Mini LE Charger and Eon Mini LE Charging System | St. Jude Medical Plano, TX 75024 |
Approval for the modification to the Model 3721 Eon Mini Charging System. The device, as modified, will be marketed under the trade name Model 3720 Eon mini LE Charger and Model 3722 Eon mini LE Charging System and is indicated as an aid in the management of chronic pain of the trunk and/or limbs, including unilateral pain associated with any of the following: failed back surgery syndrome, and chronic low back/leg pain. |
| P010047/S021 9/5/12 Real-Time |
NeoMend ProGel Pleural Air Leak Sealant | NeoMend, Incorporated Irvine, CA 92618 |
Approval for modifications to the Push Rod (C-00286), End Cap (C-00280) and Outer Housing (C-00279) components of the Applicator Kit and associated minor labeling changes. |
| P020009/S088 9/27/12 135-Day |
Express 2 Monorail and OTW Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a modified configuration of the carrier coil used in product packaging. |
| P020045/S045 9/21/12 Real-Time |
7F Freezor Cardiac CryoAblation Catheter, Cryoconsole, 7F Freezor Xtra Surgical Device and Cryoconsole and 9F Freezor MAX Surgical Catheter and Cryoconsole |
Medtronic CryoCath, LP Kirkland, Quebec Canada H9H 5H3 |
Approval for modifications to the firmware and software which is upgraded from version 4.03 to 4.04.080 for the devices. |
| P020050/S008 9/7/12 Real-Time |
ALLEGRETTO WAVE® EYE-Q Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for introduction of a new notebook computer model (Toshiba Tecra A11 ) to replace the current notebook model (Toshiba Tecra M10) which is being phased out by the manufacturer. This will require a change in the operating system from Windows 2000 to Windows XP Service Pack 2 as the new notebook computer will not be supported by the old system. |
| P030008/S008 9/7/12 Real-Time |
ALLEGRETTO WAVE® EYE-Q Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for introduction of a new notebook computer model (Toshiba Tecra A11 ) to replace the current notebook model (Toshiba Tecra M10) which is being phased out by the manufacturer. This will require a change in the operating system from Windows 2000 to Windows XP Service Pack 2 as the new notebook computer will not be supported by the old system. |
| P030035/S099 9/6/12 Real-Time |
Frontier/Frontier II/ Anthem Family of CRT-Ps | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Approval for an update to the pace and sense integrated circuit. |
| P030054/S227 9/6/12 180-Day |
Quadra Assura and Unify Assura CRT-Ds |
St. Jude Medical Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Operations Malaysia (SJM-MYPE) in Penang, Malaysia. |
| P040016/S091 9/27/12 135-Day |
VeriFLEX (Liberté) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a modified configuration of the carrier coil used in product packaging. |
| P040023/S024 9/6/12 Special |
Duraloc Option Ceramic Hip System | DePuy Orthopaedics, Incorporated Warsaw, IN 46581 |
Approval for the addition of an independent inspector to perform visual check of the S-ROM femoral stem component sterile packaging. |
| P040033/S018 9/11/12 180-Day |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for a manufacturing site located in Warwick, United Kingdom. |
| P050027/S004 9/10/12 Special |
Karl Storz Photodynamic D-Light C (PDD) System |
Karl Storz Endoscopy-America, Inc. El Segundo, CA 90245 |
Approval of corrections to the Ethylene Oxide (EtO) sterilization instructions contained in the PDD Camera Heads instruction card, Hopkins II PDD Telescopes instruction manual and Tricam SL II Camera Control Unit instruction manual. |
| P050028/S023 9/18/12 135-Day |
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 |
Approval for the manufacturing changes to the DNA synthesizer instrument platform for the vialed master mix and probe reagent components. |
| P050037/S033 9/25/12 Real-Time |
Radiesse® | Merz Aesthetics, Incorporation Franksville, WI 53126 |
Approval to extend the labeled shelf life of the 3.0cc product fill volume Radiesse from 6 months to 24 months. |
| P050044/S023 9/25/12 Special |
Vitagel | Stryker Orthobiologics Malvern, PA 19355 |
Approval for the following two changes to the labeling instructions for use for the VitaPrep Plasma Separator: 1) inclusion of warning statement: "Always wear well fitting gloves when handling VitaPrep” and 2) inclusion of instructions: "Assure there is no blood in the Luer connection. If blood is present, carefully clear the area of residual blood.” |
| P050052/S036 9/25/12 Real-Time |
Radiesse® | Merz Aesthetics, Incorporated Franksville, WI 53126 |
Approval to extend the labeled shel f life of the 3.0cc product fill volume Radiesse from 6 months to 24 months. |
| P060002/S024 9/27/12 135-Day |
Bard FLAIR Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Approval for automation of an inspection step. |
| P060006/S030 9/27/12 135-Day |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a modified configuration of the carrier coil used in product packaging. |
| P060019/S022 9/7/12 Real-Time |
Therapy Cool Path Ablation Catheters | St. Jude Medical Irvine, CA 92614 |
Approval for a design modification to the bond between that catheter shaft and the extension tubing. Specifically, to change the adhesive from loctite to urethane and to modify the contact hole from a circular to an octagonal shape. |
| P060023/S002 9/13/12 135-Day |
BRYAN Cervical Disc | Medtronic Sofamor Danek USA, Inc. Memphis, TN 38132 |
Approval for a change to the injection molding process. |
| P060030/S024 9/18/12 135-Day |
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 |
Approval for the manufacturing changes to the DNA synthesizer instrument platform for the vialed master mix and probe reagent components. |
| P070006/S008 9/5/12 Real-Time |
T-SPOT® .TB Test | Oxford Immunotec, Ltd. Toms River, NJ 08754 |
Approval for a design change, for a larger reagent volume format for the T-Cell Xtend® reagent, an accessory to the T-SPOT® .TB Test, to increase the volume from 3 X 2mL vials in a pack to a 50mL bottle. |
| P070014/S030 9/27/12 135-Day |
LifeStent Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Approval for automation of an inspection step. |
| P070014/S033 9/12/12 Special |
LifeStent Vascular Stent System | C.R. Bard, Inc. Tempe, AZ 85281 |
Approval for the separation of the manufacturing and inspection responsibilities for the manual press process. |
| P070015/S070 9/7/12 180-Day |
Xience V Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval for a manufacturing site located at Abbott Nutrition in Sligo, Ireland. |
| P070015/S087 9/14/12 180-Day |
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Approval to update the product labeling contained in the Instructions for Use (IFU) and patient guide for the XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System and for the XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System. These updates specifically included longer term follow-up data to all applicable clinical trials for the devices. |
| P070015/S088 9/10/12 135-Day |
XIENCE V/ XIENCE Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval for transferring the testing of Total Organic Carbon (TOC) from a contract laboratory to Abbott Vascular in Temecula, California. |
| P070015/S094 9/19/12 180-Day |
XIENCE V®/ XIENCE nano™ Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval to change the coating integrity specification for the 28 mm length stents to align with that of the 33 mm and 38 mm stents for the XIENCE family of products. |
| P070026/S007 9/6/12 Special |
DePuy Ceramax Ceramic Total Hip System | DePuy Orthopaedics, Incorporated Warsaw, IN 46581 |
Approval for the addition of an independent inspector to perform visual check of the S-ROM femoral stem component sterile packaging. |
| P080007/S011 9/27/12 135-Day |
E-LUMINEXX Vascular Stent | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Approval for automation of an inspection step. |
| P080026/S003 9/26/12 135-Day |
RealTime HBV Assay | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for a change from a manual assembly system to an automated process for kit packaging. |
| P100010/S018 9/21/12 Real-Time |
Arctic Front Cardiac CryoAblation Catheters, Freezor MAX CryoAblation Catheter, Cryoconsole, Manual Retraction Kit and Accessories | Medtronic CryoCath, LP Kirkland, Quebec Canada H9H 5H3 |
Approval for modifications to the firmware and software which is upgraded from version 4.03 to 4.04.080 for the device. |
| P090002/S005 9/6/12 Special |
Pinnacle CoMplete Acetabular Hip System | DePuy Orthopaedics, Incorporated Warsaw, IN 46581 |
Approval for the addition of an independent inspector to perform visual check of the S-ROM femoral stem component sterile packaging. |
| P090013/S072 9/25/12 Real-Time |
Revo MRI, CardioSight Reader Monitor, CareLink Express Monitor | Medtronic, Inc. Mounds View, MN 55112 |
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor. |
| P100010/S018 9/21/12 Real-Time |
Arctic Front Cardiac CryoAblation Catheters; Freezor MAX CryoAblation Catheter; Cryoconsole; Manual Retraction Kit; and Accessories | Medtronic CryoCath, LP Kirkland, Quebec Canada H9H 5H3 |
Approval for modifications to the firmware and software which is upgraded from version 4.03 to 4.04.080 for the device. |
| P100013/S003 9/19/12 Real-Time |
EXOSEAL™ Vascular Closure Device | Cordis Corporation Miami Lakes, FL 33014 |
Approval for the patient brochure. |
| P100017/S002 9/27/12 135-Day |
RealTime HCV Assay | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for a change from a manual assembly system to an automated process for kit packaging. |
| P100023/S053 9/27/12 Real-Time |
ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for removal of the ball from the tip of the corewire which is located between the inner and outer lumen of the Stent Delivery System. The device, as modified, will be marketed under the trade PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System and ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System and are indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novolesions in native coronary arteries >2.25 mm to <4.00 mm in diameter in lesions <34 mm in length, and for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >2.25 mm to < 4.00 mm in diameter in lesions < 3 4 mm in length, respectively |
| P100025/S001 9/5/12 180-Day |
BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0 |
Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 |
Approval for packaging changes for the BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0. The packaging changes consist of new kit and shipper cartons along with new labeling on each of these cartons. |
| P100044/S001 9/21/12 180-Day |
Propel™ Mini Sinus Implant | Intersect ENT Palo Alto, CA 94303 |
Approval for a shortened version of the drug-eluting sinus stent. The device, as modified, will be marketed under the trade name Propel™ Mini Sinus Implant and is indicated for use in patients ≥ 18 years of age following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. The Propel Mini Sinus Implant separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema. |
| P110010/S028 9/27/12 Real-Time |
PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System |
Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for removal of the ball from the tip of the corewire which is located between the inner and outer lumen of the Stent Delivery System. The device, as modified, will be marketed under the trade PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System and ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System and are indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novolesions in native coronary arteries >2.25 mm to <4.00 mm in diameter in lesions <34 mm in length, and for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >2.25 mm to < 4.00 mm in diameter in lesions < 3 4 mm in length, respectively |
| P110016/S001 9/13/12 135-Day |
Therapy Cool Path Duo Ablation Catheter, Safire BLU Duo Ablation Catheter, and Cardiac Ablation Generator | St. Jude Medical – Irvine Biomedical Irvine, CA 92614 |
Approval for an alternate vendor to supply printed circuit boards for the 1500T9-CP v1.6 generator. |
| P110016/S004 9/7/12 Real-Time |
Therapy Cool Path Duo Ablation Catheters | St. Jude Medical Irvine, CA 92614 |
Approval for a design modification to the bond between that catheter shaft and the extension tubing. Specifically, to change the adhesive from loctite to urethane and to modify the contact hole from a circular to an octagonal shape. |
| P110019/S009 9/14/12 180-Day |
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Approval to update the product labeling contained in the Instructions for Use (IFU) and patient guide for the XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System and for the XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System. These updates specifically included longer term follow-up data to all applicable clinical trials for the devices. |
| P110019/S011 9/10/12 135-Day |
XIENCE Prime LL Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval for transferring the testing of Total Organic Carbon (TOC) from a contract laboratory to Abbott Vascular in Temecula, California. |
| P110019/S020 9/19/12 180-Day |
XIENCE PRIME™/ XIENCE PRIME LL™ Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval to change the coating integrity specification for the 28 mm length stents to align with that of the 33 mm and 38 mm stents for the XIENCE family of products. |
| P110020/S003 9/4/12 135-Day |
cobas® 4800 BRAF V600 Mutation Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a change in the DNA synthesizer instrument platform for certain vialed master mix and probe reagent components. |
| P110037/S001 9/5/12 Real-Time |
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a change to the Test Definition File (TDF). The device, as modified, will be marketed under the trade name COBAS AmpliPrep/COBAS TaqMan CMV Test and is indicated for: COBAS AmpliPrep/COBAS TaqMan CMV Test: The COBAS AmpliPrep/ COBAS TaqMan CMV Test is an in vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (CMV) DNA in human EDTA plasma using the COBAS AmpliPrcp Instrument for automated specimen processing and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer for automated amplification and detection. The COBAS AmpliPrcp/ COBAS TaqMan CMV Test is intended for usc as an aid in the management of solid-organ transplant patients who arc undergoing anti-CMV therapy. In this population serial DNA measurements can be used to assess virological response to antiviral treatment. The results from the COBAS AmpliPrep/COBAS TaqMan CMV Test must be interpreted within the context of all relevant clinical and laboratory findings. The COBAS AmpliPrep/ COBAS TaqMan CMV Test is not intended for use as a screening test for the presence of CMV DNA in blood or blood products. |
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 |
|---|---|---|---|
| P810006/S034 9/14/12 |
COLLASTAT Absorbable Collagen Hemostatic Sponge, COLLASTAT Absorbable Collagen Hemostatic Agent-Microfibrillar Form | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Change in Chart Recording System. |
| P810006/S035 9/28/12 |
CollaStat Absorbable Collagen Hemostatic Sponge CollaStat Absorbable Collagen Hemostatic Agent-Microfibrillar Form |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Upgrades to the Medical Products Manufacturing Suite. |
| P840001/S225 9/12/12 |
Restore Rechargeable/ Restore Prime/Restore Advanced/Prime Advanced/Restore Ultra/Itrel 4/ Synergy/Synergy Verstirel/Restore Sensor |
Medtronic, Inc. Minneapolis, MN 55432 |
Change the acceptance criteria for titanium content in the cables and to add an alternate supplier for the cable braiding and micro-extrusion processes. |
| P840001/S226 9/13/12 |
Itrel®, Synergy®, Restore®, Soletra®, Kinetra®, lnterstim® & Enterra® Neurostimulators |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of manufacturing equipment at the MPROC-Juncos facility germane to the devices. |
| P840062/S023 9/14/12 |
CollaCote, CollaTape and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Change in Chart Recording System. |
| P840062/S024 9/28/12 |
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Upgrades to the Medical Products Manufacturing Suite. |
| P850010/S031 9/14/12 |
HELISTAT and HELITENE Absorbable Collagen Hemostatic Agent | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Change in Chart Recording System. |
| P850010/S032 9/28/12 |
HeliStat, Helitene Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Upgrades to the Medical Products Manufacturing Suite. |
| P850079/S054 9/11/12 |
Methafilcon A and B Soft Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Relocation of a manufacturing line and installation of supporting parts. |
| P850079/S055 9/18/12 |
Methafilcon A and B Soft Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Temporary change to the inspection process. |
| P850079/S056 9/18/12 |
Methafilcon A and B Soft Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
New manufacturing line. |
| P860057/S091 9/19/12 |
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis | Edward Lifesciences, LLC Irvine, CA 92614 |
Modify the layout of an isolation clean room. |
| P870056/S051 9/19/12 |
Carpentier-Edwards Porcine Bioprosthesis | Edward Lifesciences, LLC Irvine, CA 92614 |
Modify the layout of an isolation clean room. |
| P870077/S046 9/19/12 |
Carpentier-Edwards S.A.V. Bioprosthesis | Edward Lifesciences, LLC Irvine, CA 92614 |
Modify the layout of an isolation clean room. |
| P880086/S222 9/14/12 |
Accent Family of Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Clarification of the visual inspection criteria for low voltage pulse generators. |
| P880086/S224 9/12/12 |
Accent Family of Pacemakers | St. Jude Medical, Inc. Sylmar, CA 91342` |
Alternate supplier for the electromagnetic coil receiver used in the voice coil assembly. |
| P880086/S225 9/24/12 |
Family of Pacemakers | St. Jude Medical, Inc. Sylmar, CA 91342 |
Reduction in the cure time for the room temperature vulcanized adhesive. |
| P890003/S256 9/10/12 |
Prodigy IPG | Medtronic, Inc. Mounds View, MN 55112 |
Update to the battery burn-in process and inspection methods. |
| P890003/S257 9/19/12 |
Prodigy | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new supplier for packaging materials, and a change to the orientation of an identification number on the packaging |
| P910001/S061 9/5/12 |
ELCA Coronary Artherectomy Catheter | Spectranetics Corporation Colorado Springs, CO 80921 |
Use of additional sterilization chambers at the contract sterilizer. |
| P910023/S303 9/24/12 |
Family of ICDs | St. Jude Medical, Inc. Sylmar, CA 91342 |
Reduction in the cure time for the room temperature vulcanized adhesive. |
| P920047/S053 9/21/12 |
Blazer Prime HTD Temperature Ablation Catheter | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P930031/S034 9/6/12 |
Wallstent Transjugular Portosystemic Shunt (TIPS) Endoprosthesis with Unistep Plus Delivery System |
Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P930031/S035 9/21/12 |
Wallstent Transjugular Portosystemic Shunt (TIPS) Endoprosthesis with Unistep Plus Delivery System |
Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P940019/S029 9/6/12 |
Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P940019/S030 9/21/12 |
Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P950020/S052 9/6/12 |
Flextome Cutting Balloon Dilation Device | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P950020/S053 9/7/12 |
Flextome Cutting Balloon | Boston Scientific Corporation Maple Grove, MN 55311 |
An alternate supplier for the balloon protector cap component; and minor dimensional changes for the balloon protector cap component. |
| P950020/S054 9/21/12 |
Flextome Cutting Balloon Dilation Device (Monorail & Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P960009/S115 9/13/12 |
Itrel®, Synergy®, Restore®, Soletra®, Kinetra®, lnterstim® & Enterra® Neurostimulators |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of manufacturing equipment at the MPROC-Juncos facility germane to the devices. |
| P960009/S154 9/12/12 |
Activa Tremor Control System | Medtronic, Inc. Minneapolis, MN 55432 |
Change the acceptance criteria for titanium content in the cables and to add an alternate supplier for the cable braiding and micro-extrusion processes. |
| P960040/S268 9/11/12 |
Punctua, Energen and Incepta ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of an alternate supplier for the tantalum capacitors. |
| P960040/S269 9/24/12 |
Teligen. Cognis, lncepta, Energen and Punctua ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Update to the acceptance activities for tab length measurement inspection process. |
| P960042/S041 9/5/12 |
Spectranetics Laser Sheaths SLS | Spectranetics Corporation Colorado Springs, CO 80921 |
Use of additional sterilization chambers at the contract sterilizer. |
| P970003/S151 9/6/12 |
VNS Therapy® Pulse Generators | Cyberonics, Inc. Houston, TX 77058 |
Addition of a fixture for cleaning of a component. |
| P970003/S152 9/13/12 |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Use of alternate Schottky diodes for the VNS Therapy Implantable Pulse Generators and the Programming Wand. |
| P970004/S140 9/13/12 |
Itrel®, Synergy®, Restore®, Soletra®, Kinetra®, lnterstim® & Enterra® Neurostimulators |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of manufacturing equipment at the MPROC-Juncos facility germane to the devices. |
| P970051/S095 9/5/12 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Re-commissioning of a clean room and establishment of a new manufacturing line. |
| P980016/S374 9/4/12 |
Protecta ICD, Protecta XT ICD | Medtronic, Inc. Mounds View, MN 55112 |
Software update to a CD Surge test. |
| P980016/S377 9/5/12 |
Maximo II, Protecta, Protecta XT, Secura, Virtuoso II DR/VR ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1. |
| P980016/S378 9/19/12 |
Maximo II, Protecta, Protecta XT, Secura, Virtuosos II DR/VR ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Updates to the IC wafer probe test specifications and test software. |
| P980016/S379 9/20/12 |
Maximo II DF4 CRT-D, Maximo II DF4 ICD, Maximo II ICD, Protecta DF4 ICD, Protecta ICD, Protecta XT DF4 ICD, Protccta XT ICD, Secura DF4, Secura and Virtuoso II DR/VR ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Update acceptance criteria inspection process for all die locations on all hybrids. |
| P980016/S380 9/20/12 |
Protecta and Protecta XT ICDs |
Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing test for an integrated circuit (IC) at the supplier location. |
| P980022/S121 9/13/12 |
Paradigm® REAL-Time System, Paradigm® REA L-Time REVEL System, and Guardian® REAL-Time System |
Medtronic MiniMed Northridge, CA 91325 |
Reinstatement of the Ayutthaya, Thailand facility as an additional facility for the manufacture of printed circuit board assemblies and stack subassemblies used by Medtronic MiniMed in the production of the Paradigm® REAL-Time Insulin Pump (models MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm® REAL-Time REVEL Insulin Pump (models MMT-523, MMT-523K, MMT-723, and MMT-723K)) and Guardian® REAL-Time Monitor (CSS7100, CSS7 100K). The Paradigm® REAL-Time Insulin Pump, Paradigm® REAL-Time REVEL Insulin Pump, and Guardian® REAL-Time Monitor are components of the devices. |
| P980022/S122 9/18/12 |
Paradigm® REAL-Time System, Paradigm® REA L-Time REVEL System, and Guardian® REAL-Time System, CGMS IPro System and CGMS iPro2 System |
Medtronic, Inc. Northridge, CA 91325 |
Manufacturing process change which will incorporate the addition of process water to a once-diluted batch of platinum plating solution for the Sof-Sensor Glucose Sensors (models MMT-7002 and MMT-7003) that are components of the devices. |
| P980023/S047 9/24/12 |
Linox Smart Drug- Eluting Pacing Lead | Biotronik, Inc. Lake Oswego, OR 97035 |
Adding new labeling software used to print the labels for various devices and accessories. |
| P980033/S023 9/6/12 |
Wallstent Venous Endoprosthesis with Unistep Plus Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P980033/S024 9/21/12 |
Wallstent Venous Endoprosthesis with Unistep Plus Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P980035/S286 9/5/12 |
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa, Advisa DR, Relia IPGs |
Medtronic, Inc. Mounds View, MN 55112 |
Implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1. |
| P980035/S287 9/10/12 |
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa, IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Update to the battery burn-in process and inspection methods. |
| P980035/S288 9/19/12 |
Adapta, Relia and Sensia | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new supplier for packaging materials, and a change to the orientation of an identification number on the packaging. |
| P980035/S289 9/19/12 |
Advisa DR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Updates to the IC wafer probe test specifications and test software. |
| P980044/S014 9/18/12 |
SUPARTZ® | Seikagaku Corporation Tokyo, Japan 100-0005 |
Modification of an existing water system. |
| P000007/S033 9/19/12 |
Edwards Prima Plus Stentless Bioprosthesis | Edward Lifesciences, LLC Irvine, CA 92614 |
Modify the layout of an isolation clean room. |
| P000012/S039 9/14/12 |
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/ COBAS® AMPLICOR® HCV Test Version 2.0 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change to adjust the environmental testing performed at the RMS Branchburg facility. |
| P000037/S029 9/19/12 |
On-X Prosthetic Heart Valve | On-X Technologies, Inc. Austin, TX 78752 |
Modification to the Limulus Amebocyte Lysate (LAL) test method and procedure. |
| P010012/S298 9/11/12 |
Punctua, Energen and Incepta CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of an alternate supplier for the tantalum capacitors. |
| P010012/S299 9/24/12 |
Teligen, Cognis, lncepta, Energen and Punctual CRT-Ds |
Boston Scientific Corporation St. Paul, MN 55112 |
Update to the acceptance activities for tab length measurement inspection process. |
| P010015/S172 9/5/12 |
Consulta and Syncra CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Increase in a test limit on the feed through assembly at the supplier location. |
| P010015/S173 9/5/12 |
Consulta, Syncra CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1. |
| P010015/S174 9/19/12 |
Consulta, Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Updates to the IC wafer probe test specifications and test software. |
| P010031/S327 9/4/12 |
Protecta CRT-D, Protecta XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Software update to a CD Surge test. |
| P010031/S330 9/5/12 |
Concerto II, Consulta DF4, Maximo II, Protecta, Protecta XT 1CDs and CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1. |
| P010031/S331 9/19/12 |
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD, Maximo II CRT-D, Protecta CRT-D and Protecta XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Updates to the IC wafer probe test specifications and test software. |
| P010031/S332 9/20/12 |
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD, Maximo II CRT-D, Maximo II DF4 CRT-D, Protecta CRT-D, Protecta DF4 CRT-D, Protecta XT CRT-D, Protecta XT DF4 CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Update acceptance criteria inspection process for all die locations on all hybrids. |
| P010031/S333 9/20/12 |
Protecta and Protecta XT CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing test for an integrated circuit (IC) at the supplier location. |
| P010041/S035 9/19/12 |
Carpentier-Edwards S.A.V. Bioprosthesis | Edward Lifesciences, LLC Irvine, CA 92614 |
Modify the layout of an isolation clean room. |
| P020009/S091 9/21/12 |
Express Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate equipment for dispensing and mixing urethane adhesive. |
| P020009/S092 9/21/12 |
Express 2 Coronary Stent System (Monorail & Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P020025/S035 9/21/12 |
Blazer Prime XP Temperature Ablation Catheter | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P030017/S141 9/14/12 |
Precision Spinal Cord Stimulator System | Boston Scientific Corporation Valencia, CA 91355 |
Addition of an alternate supplier for a component of the charger assembly. |
| P030017/S142 9/26/12 |
Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Valencia, CA 91355 |
Update the test systems used for the testing of the Implantable Pulse Generator (IPG) of the device. |
| P030022/S022 9/6/12 |
Reflection Ceramic Acetabular Hip System | Smith & Nephew, Inc. Memphis, TN 38116 |
Addition of an alternate vendor for the Anthology Hip Stem porous coating process. |
| P030031/S047 9/20/12 |
ThermoCool SF Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
New test equipment for the devices. |
| P030035/S100 9/14/12 |
Anthem Family of Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Clarification of the visual inspection criteria for low voltage pulse generators. |
| P030035/S102 9/12/12 |
Anthem Family of CRT-Ps | St. Jude Medical, Inc. Sylmar, CA 91342` |
Alternate supplier for the electromagnetic coil receiver used in the voice coil assembly. |
| P030035/S103 9/24/12 |
Family of CRT-Ps | St. Jude Medical, Inc. Sylmar, CA 91342 |
Reduction in the cure time for the room temperature vulcanized adhesive. |
| P030054/S231 9/24/12 |
Family of CRT-Ds | St. Jude Medical, Inc. Sylmar, CA 91342 |
Reduction in the cure time for the room temperature vulcanized adhesive. |
| P040003/S012 9/7/12 |
ExAblate System | Insightec, Ltd. Dallas, TX 75244 |
Change in the manufacturing of the transducer for the ExAblate System from a contract manufacturer to the in-house facility. |
| P040012/S049 9/21/12 |
RX Acculink Carotid Stent System | Abbott Vascular Santa Clara, CA 95054 |
Change to the dispensing system for applying controlled amounts of assembly fluids during the manufacturing process. |
| P040016/S095 9/6/12 |
VeriFLEX Coronary Stent System (Monorail) | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P040016/S096 9/21/12 |
VeriFLEX (Libertè) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate equipment for dispensing and mixing urethane adhesive. |
| P040016/S097 9/21/12 |
VeriFLEX Coronary Stent System (Monorail & Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P050006/S030 9/7/12 |
Gore Helex Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Redesigned flaring equipment and reduction of the sampling plans for the device lock release force. |
| P050006/S031 9/27/12 |
GORE HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Use of alternate cutting equipment. |
| P050019/S010 9/6/12 |
Carotid WALLSTENT Monorail Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P050028/S026 9/14/12 |
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change to adjust the environmental testing performed at the RMS Branchburg facility. |
| P050039/S011 9/27/12 |
Novation Ceramic Articulation Hip System | Exatech, Inc. Gainesville, FL 32653 |
Addition of laser marking systems for purposes of the product identification of the mating femoral stems used with the devices. |
| P060006/S033 9/21/12 |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P060007/S020 9/14/12 |
ARCHITECT HBsAg/HBsAg Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Change to a test method used in the manufacture of the components of the ARCHITECT HBsAg and HBsAg Confirmatory assay, and the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assay. |
| P060008/S094 9/6/12 |
TAXUS Libertè Paclitaxel-Eluting Platinum Chromium Coronary Stent System (Monorail) |
Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P060008/S095 9/21/12 |
TAXUS Libertè Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate equipment for dispensing and mixing urethane adhesive. |
| P060008/S096 9/21/12 |
TAXUS Libertè Paclitaxel-Eluting Platinum Chromium Coronary Stent System (Monorail & Over-the-Wire) |
Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P060030/S028 9/14/12 |
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change to adjust the environmental testing performed at the RMS Branchburg facility. |
| P070007/S036 9/21/12 |
Talent Thoracic Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Automation of a cutting/sealing step. |
| P070014/S034 9/21/12 |
LifeStent Vascular Stent System | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Addition of an alternate supplier for tantalum markers. |
| P070015/S099 9/7/12 |
XIENCE V and Nano Everolimus Eluting Coronary Stent System (EECSS) |
Abbott Vascular Temecula, CA 92591 |
Change to the method used to test for drug release. |
| P070027/S035 9/21/12 |
Talent Abdominal Stent Graft with the Xcelerant Hydro Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Automation of a cutting/sealing step. |
| P080006/S043 9/19/12 |
Attain Ability Leads | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new supplier for packaging materials, and a change to the orientation of an identification number on the packaging. |
| P080011/S017 9/27/12 |
Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Addition of an alternate supplier of raw material. |
| P080012/S006 9/13/12 |
Prometra Programmable Infusion Pump System | Flowonix Medical, Inc. Mount Olive, NJ 07828 |
New Alternate sub-tier supplier for a component of the device. |
| P080012/S007 9/11/12 |
Prometra Programmable Implantable Infusion Pump System | Flowonix Medical, Inc. Mt. Olive, NJ 07828 |
Use of an alternate sub-tier supplier for a component of the device. |
| P080025/S037 9/13/12 |
Itrel®, Synergy®, Restore®, Soletra®, Kinetra®, lnterstim® & Enterra® Neurostimulators |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of manufacturing equipment at the MPROC-Juncos facility germane to the devices. |
| P080030/S006 9/18/12 |
Glaukos Corporation iStent Trabecular Micro-Bypass Stent System | Glaukos Corporation Laguna Hills, CA 92653 |
Addition of a second clean room and to perform in house peel testing. |
| P090003/S015 9/6/12 |
Express LD Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P090013/S070 9/5/12 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1. |
| P090013/S071 9/10/12 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Update to the battery burn-in process and inspection methods. |
| P090018/S018 9/28/12 |
Esteem | Envoy Medical Corporation Saint Paul, MN 55110 |
Change to the Ear Insert Tube cleaning process. |
| P090022/S014 9/20/12 |
Softec HD, Softec I, Softec HD PS and Softec HDO Intraocular Lenses (IOLs) | Lenstec Incorporated St. Petersburg, FL 33716 |
Inclusion of two additional steam sterilizer units for the sterilization of the firm’s Softec series of IOLs. |
| P100020/S006 9/14/12 |
cobas® HPV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change to adjust the environmental testing performed at the RMS Branchburg facility. |
| P100021/S020 9/25/12 |
Endurant and Endurant II Stent Graft Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Process change to the spindle hypotube assembly to improve its adhesive properties. |
| P100023/S049 9/17/12 |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Changes to the distal bond process for the stent delivery system. |
| P100023/S052 9/6/12 |
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System (Monorail) |
Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P100023/S054 9/21/12 |
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System (Monorail & Over-the-Wire) |
Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P100040/S009 9/21/12 |
Valiant Thoracic Stent Graft with the Captivia Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Automation of a cutting/sealing step. |
| P100041/S014 9/19/12 |
Edwards SAPIEN Transcatheter Heart Valve | Edward Lifesciences, LLC Irvine, CA 92614 |
Modify the layout of an isolation clean room. |
| P110010/S024 9/17/12 |
PROMUS Element Plus Everolimus-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Changes to the distal bond process for the stent delivery system. |
| P110010/S027 9/6/12 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and OTW) | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P110010/S029 9/21/12 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail & Over-the- Wire) |
Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P110019/S030 9/7/12 |
XIENCE PR1ME and PRIME LL Everolimus Eluting Coronary stent System (EECSS) |
Abbott Vascular Temecula, CA 92591 |
Change to the method used to test for drug release. |
| P110020/S005 9/14/12 |
COBAS 4800 BRAF V600 Mutation Test | Roche Molecular, Systems, Inc. Pleasanton, CA 94558 |
Change to adjust the environmental testing performed at the RMS Branchburg facility. |
| P110027/S027 9/6/12 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail & OTW) | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P110029/S004 9/14/12 |
ARCHITECT HBsAg Qualitative/HBsAg Qualitative Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Change to a test method used in the manufacture of the components of the ARCHITECT HBsAg and HBsAg Confirmatory assay, and the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assay (P110029). |
| P110035/S003 9/21/12 |
Epic Vascular Self Expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new Statistical Process Control software. |
| P110037/S002 9/14/12 |
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change to adjust the environmental testing performed at the RMS Branchburg facility. |
| P110043/S001 9/7/12 |
Omnilink Elite Vascular Balloon Expandable Stent System | Abbott Vascular, Inc. Temecula, CA 92580 |
New straightness test for cobalt chromium stent tubing. |
| P110043/S002 9/24/12 |
Omnilink Elite Vascular Stent System | Abbott Vascular, Inc. Temecula, CA 92580 |
Changes to the extruded tubing process. |
