
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 64
Summary of PMA Originals Under Review
Total Under Review: 65
Total Active: 30
Total On Hold: 35
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 573
Total Active: 407
Total On Hold: 166
Number Greater Than 180 Days: 4
Summary of All PMA Submissions Received
Originals: 2
Supplements: 76
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 64
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 221.8
FDA Time: 188.6Days MFR Time: 33.2 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P080030 6/25/12 |
Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and Inserter (GTS-l00i) | Glaukos Corporation Laguna Hills, CA 92653 |
Approval for the Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and inserter (GTS-l00i). This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. |
P090026 6/14/12 |
Access® Hybritech® p2PSA on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the Access® Hybritech® p2PSA on the Access Immunoassay Systems. This device is indicated for: The Access Hybritech p2PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of [-2]proPSA antigen, an isoform of free PSA, in human serum using the Access Immunoassay Systems. Access Hybritech p2PSA is intended to be used in combination with Access Hybritech (total) PSA and Access Hybritech free PSA to calculate the Beckman Coulter Prostate Health Index (phi), an In Vitro Diagnostic Multivariate Index Assay (IVDMIA). Beckman Coulter phi as calculated using the Access Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA ≥ 4.0 to ≤ 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsyis required for diagnosis of cancer. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P810025/S027 6/14/12 180-Day |
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices (OVD) | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 |
Approval for a manufacturing site change and change in terminal sterilization method (i.e., E-beam to Vapor Hydrogen Peroxide) of the product. |
P860008/S021 6/5/12 135-Day |
TAPSCOPE 550 | CardioCommand, Inc. Tampa, FL 33607 |
Approval of a new supplier for the molding of the pacing wire connector and revision to the manufacturing process of the pacing wire assembly. |
P890003/S247 6/4/12 180-Day |
DDMA Software | Medtronic, Inc. Mounds View, MN 55112 |
Approval for DDMA Software Model 2491. |
P890055/S040 6/25/12 Real-Time |
MedStream Programmable Infusion System | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval for software modifications to the Programmable Infusion System. These modifications were data integrity check improvement, resolution of Control Unit keyboard, frame check sequence algorithm upgrade, software anomalies 015, 016, 017, 020 fix, and improvement of the Bridge Bolus, Priming Bolus and Single Bolus processes. |
P900023/S052 6/26/12 180-Day |
Ipulse™ Circulatory Support System | Abiomed, Inc. Danvers, MA 09123 |
Approval for correction of the AB5000 Driver Failure Notification alarm, addition of a delay circuit to the external AB Portable Power Supply, and correction to the Ipulse Driver Plenum Seal. |
P910077/S121 6/19/12 Real-Time |
LATTIUDE Communicator | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of the option to connect the LATTITUDE Communicator to an off-the-shelf commercially available cellular modem. |
P930014/S058 6/7/12 180-Day |
Acrysof® Toric and Acrysof® IQ Toric High Cylinder Power IOLs | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval of the post-approval study protocol. |
P950022/S081 6/28/12 135-Day |
Durata Family of Leads | St. Jude Medical Sylmar, CA 91342 |
Approval for implementation of a new automated tester. |
P960040/S078 6/22/12 Special |
VENTAK AV AICD Families | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the minor manufacture changes of the devices. |
P960040/S261 6/19/12 Real-Time |
PUNCTUA ICD, ENERGEN ICD and INCEPTA ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for modifying the design specifications for the spot weld anchor post used in ICD and CRT-D Pulse Generator (PG) headers and the leaf spring housing block used in the LV-1 for CRT-D Pulse Generator headers. |
P960058/S095 6/15/12 180-Day |
HiResolution Bionic Ear System | Advanced Bionics, LLC Sylmar, CA 91342 |
Approval for a manufacturing site located at Advanced Bionics, LLC and a finished goods warehouse located in Valencia, California. |
P980016/S343 6/4/12 180-Day |
Maximo II ICD, Secura ICD, and Virtuoso II DR/VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Approval for Maximo II ICD Models D264DRM, D284DRG, D284VRC; Secura ICD Models D204DRM, D224DRG, D224VRC; and Virtuoso II DR/VR ICD Models D274DRG and D274VRC. |
P980018/S015 6/8/12 180-Day |
HercepTest™ | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Approval for addition of pertuzumab in the labeling of HercepTest™. The device, as modified, will be marketed under the trade name HercepTest™ and its indication for use is: “HercepTest™ is a semi-quantitative immunohisto-chemical assay to determine HER2 protein overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest™ is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being considered and for breast cancer patients for whom PERJETA™ (pertuzumab) treatment is being considered (see Herceptin® and PERJETA™ package inserts)." |
P980022/S103 6/19/12 135-Day |
Medtronic MiniMed Continuous Glucose Monitoring System, Paradigm REAL-Time System, Guardian REAL-Time System, CGMS iPro System, CGMS iPro2 System |
Medtronic, Inc. Northridge, CA 91325 |
Approval for a manufacturing process change to incorporate the addition of process water to a used batch of platinum plating solution for the Sof Sensor Glucose Sensors (models MMT-7002 and MMT-7003) that are components of the Medtronic MiniMed Continuous Glucose Monitoring System, the Paradigm REAL-Time System, the Guardian REAL-Time System, the CGMS iPro System and the CGMS iPro2 System. |
P980035/S264 6/4/12 180-Day |
Advisa DR IPG and Application Software for CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Advisa DR IPG Model A4DR01 and Application Software Model 9995 Version 7.4 for CareLink Programmer Model 2090. |
P990046/S029 6/25/12 180-Day |
Open Pivot Heart Valve | Medtronic, Inc. Minneapolis, MN 55447 |
Approval of the post-approval study protocol. |
P000012/S038 6/7/12 180-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 a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey. |
P000023/S007 6/27/12 180-Day |
TMJ Fossa-Eminence and Condylar Prosthesis System | TMJ Medical Golden, CO 80401 |
Approval for a manufacturing site located at TMJ Medical in Golden, Colorado. |
P000035/S007 6/27/12 180-Day |
TMJ Fossa-Eminence and Prosthesis System | TMJ Medical Golden, CO 80401 |
Approval for a manufacturing site located at TMJ Medical in Golden, Colorado. |
P000037/S025 6/8/12 135-Day |
On-X Prosthetic Heart Valve | On-X Life Technologies Austin, TX 78752 |
Approval to move the machining process for size 25 valve housing substrates in-house. |
P000040/S024 6/19/12 Real-Time |
GeneSys HTA™ System | Boston Scientific Corporation Marlborough, MA 01752 |
Approval for minor changes to the electrical design of the controller. |
P010012/S069 6/22/12 Special |
CONTAK CD Families | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the minor manufacture changes of the devices. |
P010012/S291 6/19/12 Real-Time |
PUNCTUA CRT-D, ENERGEN CRT-D and INCEPTA CRT-D | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for modifying the design specifications for the spot weld anchor post used in ICD and CRT-D Pulse Generator (PG) headers and the leaf spring housing block used in the LV-1 for CRT-D Pulse Generator headers. |
P010015/S157 6/4/12 180-Day |
Consulta CRT-P and Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Approval for Consulta CRT-P Model C4TR01 and Syncra CRT-P Model C2TR01. |
P010030/S025 6/29/12 Real-Time |
LifeVest Wearable Defibrillator | ZOLL LifeCor Corporation Pittsburgh, PA 15238 |
Approval for design changes to the LifeVest garment including location of the rear therapy pads and vibration box, method of securing vibration box to garment, adjustment mechanism for shoulder strap, width of elastic strap and related labeling changes. |
P010031/S296 6/4/12 180-Day |
Concerto II CRT-D, Consulta CRT-D and Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Approval for Concerto II CRT-D Model D274TRK, Consulta CRT-D Models D204TRM and D224TRK and Maximo II CRT-D Models D264TRM and D284TRK. |
P010031/S0304 6/29/12 180-Day |
Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
Medtronic, Inc. Mounds View, MN 55112 |
Approval of the post-approval study protocol |
P010041/S030 6/26/12 180-Day |
S.A.V. Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for the labeling change based on the post-approval study data. |
P020011/S005 6/25/12 180-Day |
VERSANT® HCV RNA Qualitative Assay and APTIMA® HCV RNA Qualitative Assay` | Gen-Probe Incorporated San Diego, CA 92121 |
Approval for a device name change. The device, as modified, will be marketed under the trade name VERSANT® HCV RNA Qualitative Assay and APTIMA® HCV RNA Qualitative Assay and is indicated for the detection of hepatitis C virus (HCV) RNA in human plasma (EDTA, sodium heparin, sodium citrate, and ACD) or serum. |
P030011/S012 6/26/12 135-Day |
Syncardia Temporary Total Artificial Heart (TAH-T) System | Syncardia Systems, Inc. Tucson, AZ 85713 |
Approval for relocation of a polymer manufacturing process. |
P030016/S023 6/8/12 180-Day |
Visian ICL™ (Implantable Collamar Lens) | STAAR Surgical Company Monrovia, CA 91016 |
Approval of the post-approval study protocol. |
P030022/S021 6/28/12 135-Day |
Reflection Ceramic Hip System | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for addition of an alternate site for the machining processes for R3 Acetabular Shells. |
P030031/S039 6/15/12 180-Day |
Thermo Cool SF Bi-Directional and Uni-Directional Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for an alternative sterilization facility located at Sterigenics US in Santa Teresa, New Mexico. |
P030036/S039 6/6/12 135-Day |
SelectSecure Leads | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a new laser welder and updated weld parameters. |
P040002/S037 6/1/12 Real-Time |
AFX Endovascular AAA System | Endologix, Inc. Irvine, CA 92618 |
Approval for a modification to the SurePass contralateral limb wire subassembly. |
P040005/S006 6/8/12 180-Day |
HER2 FISH pharmDx™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Approval for addition of pertuzumab in the labeling of HER2 FISH pharmDx™ Kit. The device, as modified, will be marketed under the trade name HER2 FISH pharmDx™ Kit and its indication for use is: "a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HER2 FISH pharmDx™ Kit is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being considered and for breast cancer patients for whom PERJETA™ (pertuzumab) treatment is being considered (see Herceptin® and PERJETA™ package inserts)." |
P040023/S021 6/15/12 180-Day |
Duraloc Ceramic Hip | Depuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval of the post-approval study protocol. |
P050028/S024 6/7/12 180-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 a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey. |
P050028/S025 6/29/12 Real-Time |
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 changes to AMPLILINK Software v3.3.6. |
P050037/S028 6/20/12 180-Day |
Radiesse Injectable Implant | Merz Aesthetics, Inc. Frankville, WI 53126 |
Approval for the addition of safety and effectiveness clinical data and Post-Marketing Surveillance data from the Post Approval studies performed as a condition of approval for the Radiesse Injectable Implant. The device, as modified, will be marketed under the trade name Radiesse Injectable Implant and is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. |
P050045/S004 6/1/12 135-Day |
TOP2A FISH pharmaDx™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Approval for the manufacturing process of PNA oligomers in the device. |
P050052/S031 6/20/12 180-Day |
Radiesse Injectable Implant | Merz Aesthetics, Inc. Frankville, WI 53126 |
Approval for the addition of safety and effectiveness clinical data and Post-Marketing Surveillance data from the Post Approval studies performed as a condition of approval for the Radiesse Injectable Implant. The device, as modified, will be marketed under the trade name Radiesse Injectable Implant and is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. |
P050053/S025 6/27/12 Special |
InFuse Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for the proposed labeling revisions related to the appearance of the reconstituted product and warning statement about use in patients suspected of having cancer at the product application site. |
P060022/S012 6/18/12 180-Day |
Akreos Posterior Chamber Intraocular Lens (IOL) | Bausch & Lomb Inc. Aliso Viejo, CA 92656 |
Approval for modifications to the primary packaging which includes an alternate plastic vial and Intraocular Lens (IOL) holder. |
P060030/S025 6/7/12 180-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 a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey. |
P060030/S026 6/29/12 Real-Time |
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 changes to AMPLILINK Software v3.3.6. |
P060040/S015 6/5/12 180-Day |
Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 |
Approval for updating the HeartMate II LVAS Instructions for Use to reflect the post-approval study findings for the bridge-to-transplant indication. |
P060040/S018 6/22/12 180-Day |
Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 |
Approval for the Sealed Outflow Graft Bend Relief Collar (SOBR Collar). |
P060040/S021 6/5/12 Real-Time |
Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 |
Approval for the HeartMate II Universal Percutaneous Bend Relief Repair Kit. |
P070004/S004 6/7/12 180-Day |
Silicone Gel Breast Implants | Sientra, Inc. Santa Barbara, CA 93117 |
Approval of the post-approval study protocol. |
P080004/S008 6/13/12 135-Day |
Hoya iSpheric Intraocular Lens (IOL) | Hoya Surgical Optics, Inc. Chino Hills, CA 91709 |
Approval to expand intraocular lens manufacturing. |
P080032/S009 6/26/12 180-Day |
Alair® Bronchial Thermoplasty System | Boston Scientific Corporation Sunnyvale, CA 94089 |
Approval of the post-approval study protocol. |
P090018/S016 6/22/12 180-Day |
Esteem – Nano Sensor and Driver | Envoy Medical Corporation Saint Paul, MN 55110 |
Approval to add new, physically smaller, Sensor/ Driver models to the Esteem family. |
P090022/S011 6/11/12 Real-Time |
Softec HDO Posterior Chamber Intraocular Lens (IOL) | Lenstec, Inc. St. Petersburg, FL 33716 |
Approval for modifications to the optic body shape and overall diameter of your Softec HD lens to introduce a lens with an ovoid optic and overall diameter of 12.50 mm and changes to your labeling related to the introduction of the modified lens. The device, as modified, will be marketed under the trade name Softec HDO and is indicated for the replacement of the human crystalline lens following phacoemulsifica- tion cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement. |
P100020/S003 6/7/12 180-Day |
COBAS® HPV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey. |
P100029/S013 6/29/12 Real-Time |
Trifecta™ Valve | St. Jude Medical St. Paul, MN 55117 |
Approval for a change to the Trifecta valve stent specification to require 100% inspection for wall thickness at a new, single location – stent rail. |
P100049/S001 6/22/12 180-Day |
Linx Reflux Management System | Torax Medical Shoreview, MN 55126 |
Approval of the post-approval study protocol. |
P100049/S002 6/22/12 180-Day |
Linx Reflux Management System | Torax Medical Shoreview, MN 55126 |
Approval of the post-approval study protocol. |
P110001/S003 6/26/12 180-Day |
Herculink Elite Renal Stent System | Abbott Vascular Santa Clara, CA 95054 |
Approval for post-approval study protocol. |
P110010/S001 6/1/12 Panel-Track |
PROMUS® Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire) |
Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the PROMUS® Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire). This device is 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. |
P110012/S001 6/7/12 135-Day |
Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for addition of an alternate supplier for the Human Placental (HP) DNA component for the device, per design verification protocol MD17892. |
P110022/S001 6/18/12 180-Day |
Elecsys Anti-HBc IgM on cobas e 601 | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Approval for manufacturing site located at Roche Diagnostics GmbH, in Mannheim, Germany. |
P110025/S001 6/18/12 180-Day |
Elecsys Anti-HBc IgM on MODULAR ANALYTICS E170 | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Approval for manufacturing site located at Roche Diagnostics GmbH, in Mannheim, Germany. |
P110031/S001 6/18/12 180-Day |
Elecsys Anti-HBc IgM on cobas e 411 | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Approval for manufacturing site located at Roche Diagnostics GmbH, in Mannheim, Germany. |
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 |
---|---|---|---|
P810032/S061 6/21/12 |
PMMA Multi-piece Posterior Chamber Lens | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval of the Monofilament Draw Line System. |
P840001/S214 6/5/12 |
Restore Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate qualified sub-tier supplier for components used in patient programmers. |
P840001/S215 6/8/12 |
Restore®, Itrel®, Synergy® and SCS Products Kitted for Distribution Convenience | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of a new sealer used to heat seal adhesive coated lids to thermoformed plastic blister style trays. |
P840001/S216 6/7/12 |
SCS Implantable Neurostimulators/ SCS Leads/SCS Accessories/ SCS Extensions/ SCS Product Kitted for Distribution Convenience |
Medtronic, Inc. Minneapolis, MN 55432 |
Update the software used at several Medtronic’s manufacturing facilities. |
P840001/S217 6/15/12 |
SCS INS Itrel Family and SCS INS Synergy Family | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change to automate the manual rate check (post- sterilization test) for the impacted devices. |
P850079/S052 6/28/12 |
CooperVision Methafilcon A and B Soft Extended Wear Contact Lenses | CooperVision, Incorporated Pleasanton, CA 94588 |
Change in the supplier’s method of manufacturing a raw material used to produce contact lenses. |
P860004/S168 6/5/12 |
Synchromed Drug Pumps | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate qualified sub-tier supplier for components used in patient programmers. |
P860004/S169 6/7/12 |
Drug Delivery Accessories/Drug Delivery Kits for Revisions/SynchroMed Implantable Infusion Pump/Drug Delivery Catheters | Medtronic, Inc. Minneapolis, MN 55432 |
Update the software used at several Medtronic’s manufacturing facilities. |
P860004/S170 6/6/12 |
SynchroMed II Infusion Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change to the laser weld process for the SynchroMed II Infusion Pump, 8637. |
P860004/S171 6/18/12 |
SynchroMed II Implantable Infusion Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change to the reading of the serial number on a component for the SynchroMed II Implantable Infusion Pump, Models and 8637-20 and 8637-40. |
P870072/S048 6/18/12 |
Thoratec Ventricular Assist Device | Thoratec Corporation Pleasanton, CA 94588 |
Automation of the oven-drying process. |
P870072/S049 6/29/12 |
Thoratec Ventricular Assist Device (VAD) System | Thoratec Corporation Pleasanton, CA 94588 |
Change in supplier for a critical component. |
P890055/S041 6/28/12 |
MedStream Programmable Infusion System | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Changes to the cleaning of components during manufacturing. |
P900009/S033 6/6/12 |
EXOGEN 4000+ Ultrasound Bone Healing System | Smith & Nephew, Inc. Cordova, TN 38016 |
Change in supplier. |
P900056/S115 6/20/12 |
Rotablator Rotational Atherectomy System | Boston Scientific Corporation Maple Grove, MN 55311 |
Removal of two inspection steps from RotaLink Burr assembly process. |
P900060/S051 6/29/12 |
CarboMedics Prosthetic Heart Valve | Sorin Group USA Inc. Arvada, CO 80004 |
Adding machining operations for a component to your Sorin Biomedica Cardio S.r.l. facility. |
P910018/S016 6/19/12 |
Liposorber LA-15 System | Kaneka Pharma America, LLC. New York, NY 10036 |
Change in the location of a supplier’s manufacturing facility that produces components used in the manufacturing of the device. |
P930014/S062 6/21/12 |
AcrySof Posterior Chamber Lens | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval of the Monofilament Draw Line System. |
P930031/S031 6/6/12 |
Wallstent TIPS Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Removal of two in-process cleaning steps. |
P940015/S026 6/22/12 |
Synvisc® & Synvisc-One® | Genzyme Corporation Ridgefield, NJ 07657 |
Addition of a new water treatment system. |
P950020/S050 6/18/12 |
Coronary Flextome Cutting Balloon | Boston Scientific Corporation Maple Grove, MN 55311 |
Process change and relocation for proximal catheter marking. |
P950029/S068 6/11/12 |
Reply SR, DR and Esprit SR, DR | Sorin CRM USA, Inc. Plymouth, MN 55441 |
Alternate manufacturing equipment. |
P960009/S145 6/5/12 |
Activa Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate qualified sub-tier supplier for components used in patient programmers. |
P960009/S146 6/8/12 |
Activa®, Soletra® and Kinetra® | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of a new sealer used to heat seal adhesive coated lids to thermoformed plastic blister style trays. |
P960009/S147 6/7/12 |
DBS Accessories/DBS Leads/DBS Screening Systems/DBS Extensions/DBS Implantable Neurostimulators |
Medtronic, Inc. Minneapolis, MN 55432 |
Update the software used at several Medtronic’s manufacturing facilities. |
P960009/S148 6/15/12 |
DBS INS Soletra Family and DBS INS Kinetra Family | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change to automate the manual rate check (post- sterilization test) for the impacted devices. |
P960040/S260 6/4/12 |
Incepta ICD, Energen ICD, Punctua ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Updates to an existing component inspection process. |
P960040/S263 6/25/12 |
Teligen, Incepta, Energen, Punctua, Confient ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier for seal plugs used in the pulse generators. |
D970003/S136 6/25/12 |
Altrua, Advantion, Ingenio Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier for seal plugs used in the pulse generators. |
P970003/S149 6/20/12 |
VNS Therapy® System | Cyberonics, Inc. Houston, TX 77058 |
New routing fixture in the manufacture of the Pulse Generator Printed Circuit Board Assembly. |
P970004/S134 6/5/12 |
InterStim Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate qualified sub-tier supplier for components used in patient programmers. |
P970004/S135 6/8/12 |
InterStim® | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of a new sealer used to heat seal adhesive coated lids to thermoformed plastic blister style trays. |
P970004/S136 6/7/12 |
SNS Urinary Screening Systems/SNS Urinary Accessories/ SNS Urinary InterStim Family of Implantable Neurostimulators/ SNS Urinary Leads/ SNS Urinary Extensions/SNS UrinaryAccessories | Medtronic, Inc. Minneapolis, MN 55432 |
Update the software used at several Medtronic’s manufacturing facilities. |
P970037/S008 6/14/12 |
AutoDELFIA Xpress hAFP Test System | PerkinElmer, Inc. Indianapolis, IN 46236 |
Second alternative type of TOPO (Trioctylphosphine oxide) raw material type used in the manufacturing of the Enhancement Solution for the device. |
P980016/S352 6/4/12 |
Maximo II DF4, Maximo II lCD, Protecta DF4, Protecta lCD, Protecto XT DF4, Protecta XT lCD, Secura DF4, Secura lCD, Virtuoso II DR/VR lCD |
Medtronic, Inc. Mounds View, MN 55112 |
Incorporate plating bake test as part of the monitoring control plan performed at the supplier. |
P980016/S353 6/13/12 |
Protecta XT VR, Protecta VR, Secura VR and Maxmio II VR DF4 ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Align the header manufacturing processes of the Protecta XT VR (D314VRM), Protecta VR (D334VRM), Secura VR (D204VRM) and Maxmio II VR (D264VRM) DF4 ICDs with currently manufactured devices. |
P980016/S354 6/11/12 |
Protecta XT DR/VR, Protecta DR/VR, Secura DR/VR and Maxmio II DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Change to the connector contact assembly pull test sample configuration. |
P980016/S355 6/15/12 |
Protecta, Protecta DF4, Protecta XT and Protecta XT DF4 ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Update the software on a hybrid tester used for product acceptance testing. |
P980016/S356 6/19/12 |
Protecta ICD/DF4 ICD/XT ICD/XT DF4 ICD | Medtronic, Inc. Mounds View, MN 55112 |
Update to a software package used in product acceptance testing. |
P980016/S358 6/25/12 |
Secura VR, Maximo II VR, Protecta VR, Protecta XT VR, Secura DR, Maximo II DR, Protecta DR and Protecta XT DR | Medtronic, Inc. Mounds View, MN 55112 |
Update to the vendor inspection of a flex component, a change to the die attach cure process and removal of parallel gap welding line testing. |
P980033/S020 6/6/12 |
Wallstent Venous Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Removal of two in-process cleaning steps. |
P980035/S271 6/14/11 |
Advisa DR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Update the hybrid test software. |
P980049/S073 6/11/12 |
Paradym VR, DR and Paradym RF, SR, DR | Sorin CRM USA, Inc. Plymouth, MN 55441 |
Alternate manufacturing equipment. |
P000039/S046 6/6/12 |
AMPLATZER Septal and Cribriform Occluders | AGA Medical Corporation Plymouth, MN 55442 |
Use of different braiding equipment to reduce the potential for abrasion of Nitinol wire. |
P010012/S290 6/4/12 |
Incepta CRT-D, Energen CRT-D, Punctua CRT-D | Boston Scientific Corporation St. Paul, MN 55112 |
Updates to an existing component inspection process. |
P010012/S293 6/25/12 |
Cognis, Incepta, Punctua, Livian CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier for seal plugs used in the pulse generators. |
P010015/S163 6/14/12 |
Consulta CRT-P and Synca CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Update the hybrid test software. |
P010030/S033 6/22/12 |
LifeVest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Additional welding equipment. |
P010031/S306 6/4/12 |
Concerto II CRT-D, Consulta, Consulta DF4, Maximo II CRT-D, Maximo II DF4, Protecta CRT-D, Protecta DF4, Protecta XT CRT-D Protecta XT DF4 |
Medtronic, Inc. Mounds View, MN 55112 |
Incorporate plating bake test as part of the monitoring control plan performed at the supplier. |
P010031/S307 6/11/12 |
Protecta XT CRT-D, Protecta CRT-D, Consulta CRT-D and Maximo II CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Change to the connector contact assembly pull test sample configuration. |
P010031/S308 6/15/12 |
Protecta, Protecta DF4, Protecta XT and Protecta XT DF4 CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Update the software on a hybrid tester used for product acceptance testing. |
P010031/S309 6/19/12 |
Protecta CRT-D/ DF4 CFT-D/XT CRT-D/XT DF4 CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Update to a software package used in product acceptance testing. |
P010031/S311 6/25/12 |
Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D and Protecta XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Update to the vendor inspection of a flex component, a change to the die attach cure process and removal of parallel gap welding line testing. |
P010032/S052 6/22/12 |
Axxess Leads | St. Jude Medical Plano, TX 75024 |
Change to the Axxess Lead functional test procedure. |
P020024/S036 6/6/12 |
AMPLATZER Duct Occluders | AGA Medical Corporation Plymouth, MN 55442 |
Use of different braiding equipment to reduce the potential for abrasion of Nitinol wire. |
P020045/S043 6/14/12 |
Universal CryoConsole Mounds View, MN 55112 |
Medtronic CryoCath LP Mounds View, MN 55112 |
New supplier for a pressure transducer component. |
P020047/S048 | MULTI-LINK 8 Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Removal of a final product test for reliability engineering. |
P030005/S084 6/25/12 |
Invive CRT-P | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier for seal plugs used in the pulse generators. |
P030017/S135 6/6/12 |
Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Valencia, CA 91355 |
Change to the welding process in the manufacturing of the device. |
P030054/S222 6/20/12 |
Unify Quadra CRT-D, Unify Quadra Assura |
St. Jude Medical Sylmar, CA 91342 |
Alternate supplier of the RF antenna module. |
P040012/S045 6/21/12 |
Acculink Carotid Stent System | Abbott Vascular Temecula, CA 92591 |
Reduce the number of samples used from each lot during pyrogen testing. |
P040020/S042 6/21/12 |
AcrySof ReSTOR Posterior Chamber Lens | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval of the Monofilament Draw Line System. |
P040023/S022 6/15/12 |
Duraloc Option Ceramic Hip System | DePuy Orthopaedics Inc. Warsaw, IN 46581 |
Changes to the device sterile packaging. |
P040038/S025 6/21/12 |
ACT Carotid Stent System | Abbott Vascular Temecula, CA 92591 |
Reduce the number of samples used from each lot during pyrogen testing. |
P040040/S021 6/6/12 |
AMPLATZER Muscular VSD Occluders | AGA Medical Corporation Plymouth, MN 55442 |
Use of different braiding equipment to reduce the potential for abrasion of Nitinol wire. |
P050006/S028 6/1/12 |
Gore Helex Septal Occluder | W. L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Modification to a specification of a raw component for the manufacturing of the subject device. |
P050012/S047 6/29/12 |
Dexcom SEVEN® and SEVEN® PLUS Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Manufacturing change to semi-automate the assembly and ultraviolet bonding process for the cannula carrier (MT9754-01), pushrod carrier (MT9755-01) and needle carrier (MT9576-02) assemblies used in the sensor applicator component of the device. |
P050047/S025 6/7/12 |
JUVÉDERM Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Scale-up of an in-process manufacturing step of the device. |
P060002/S026 6/18/12 |
Bard FLAIR Endovascular Stent Graft | C. R. Bard, Inc. Tempe, AZ 85281 |
Addition of a quality control measuring microscope for component inspection. |
P060027/S040 6/11/12 |
Paradym CRT-D, RF CRT-D | Sorin CRM USA, Inc. Plymouth, MN 55441 |
Alternate manufacturing equipment. |
P060029/S004 6/29/12 |
Ethicon Omnex Surgical Sealant | Ethicon, Inc. Somerville, NJ 08876 |
Transfer of the incoming inspection process from Ethicon, Inc. in Raleigh, North Carolina to Ethicon LLC in San Lorenzo, Puerto Rico. |
P070026/S006 6/15/12 |
Ceramax Ceramic Total Hip System | DePuy Orthopaedics Inc. Warsaw, IN 46581 |
Changes to the device sterile packaging. |
P080007/S014 6/18/12 |
Bard E-LUMINEXX Vascular Stent | C. R. Bard, Inc. Tempe, AZ 85281 |
Addition of a quality control measuring microscope for component inspection. |
P080011/S012 6/19/12 |
CooperVision Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Relocation and revalidation of a manufacturing line number 3. |
P080025/S031 6/5/12 |
InterStim Therapy for Bowel Control | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate qualified sub-tier supplier for components used in patient programmers. |
P080025/S032 6/8/12 |
InterStim® | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of a new sealer used to heat seal adhesive coated lids to thermoformed plastic blister style trays. |
P080025/S033 6/7/12 |
SNS Bowel Screening Systems/SNS Bowel Accessories/SNS Bowel InterS tim Family of Implantable Neurostimulators/ SNS Bowel Leads/ SNS Bowel Extensions/SNS Bowel Accessories |
Medtronic, Inc. Minneapolis, MN 55432 |
Update the software used at several Medtronic’s manufacturing facilities. |
P090002/S004 6/15/12 |
Pinnacle CoMplete Ceramic-on-Metal Acetabular Hip System | DePuy Orthopaedics Inc. Warsaw, IN 46581 |
Changes to the device sterile packaging. |
P100021/S017 6/7/12 |
Endurant Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Inclusion of manufacturing for an additional stent ring size for the device at Empalme, Mexico. |
P110001/S004 6/7/12 |
Herculink Elite Renal Stent System | Abbott Vascular Temecula, CA 92591 |
Changes to the extruded tubing process. |
P110001/S005 6/21/12 |
RX Herculink Elite Renal and Biliary Stent System | Abbott Vascular Temecula, CA 92591 |
Reduce the number of samples used from each lot during pyrogen testing. |
P110019/S019 6/7/12 |
XIENCE PRIME and XIENCE PRIME Everolimus Eluting Coronary Stent Systems (EECSS) | Abbott Vascular Temecula, CA 92591 |
Changes to the extruded tubing process. |
P110019/S021 6/18/12 |
XIENCE PRIME Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Removal of a final product test for reliability engineering. |
P110023/S001 6/6/12 |
EverFlex Self-Expanding Peripheral Stent System | Ev3, Inc. Plymouth, MN 55441 |
Addition of a 7-pallet sterilizer vessel at the contract sterilizer. |
P110023/S002 6/14/12 |
EverFlex Self- Expanding Peripheral Stent System | Ev3, Inc. Plymouth, MN 55441 |
Reduction of the UV intensity used to cure the bonding adhesive of the manifold sub- assembly process. |
P110028/S001 6/7/12 |
Absolute Pro Vascular Self-Expanding Stent System | Abbott Vascular, Inc. Temecula, CA 92591 |
Changes to the extruded tubing process. |
P110028/S002 6/20/12 |
Absolute Pro Vascular Self-Expanding Stent System | Abbott Vascular, Inc. Temecula, CA 92591 |
Reduction of sampling frequency for a manufacturing process. |
P110028/S003 6/21/12 |
Absolute Pro Vascular Self-Expanding Stent System | Abbott Vascular, Inc. Temecula, CA 92591 |
Reduce the number of samples used from each lot during pyrogen testing. |
P110035/S001 6/6/12 |
Epic Vascular Self-Expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Update to a supplier gel rating methodology and specification. |