The Food & Drug Administration released a list of pre-market approvals granted in April:
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P100018 4/6/11 |
Pipeline™ Embolization Device | ev3, Inc. Menlo Park, CA 94025 |
Approval for the Pipeline™ Embolization Device. This device is indicated for the endovascular treatment of adults (age 22 and above) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. |
| P100020 4/19/11 180-Day |
cobas HPV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for the cobas HPV Test. cobas HPV Test Indications for Use: The cobas HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus (HPV) in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas HPV Test is indicated: 1) To screen patients 21 years and older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy; and 2) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy; 3) In women 30 years and older, the cobas HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management; and 4) In women 30 years and older, the cobas HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas HPV Test include the following liquid based collection media and collection device: a) ThinPrep Pap Test PreserCyt Solution; and b) Endocervical Brush/ Spatula. |
| P100023 4/22/11 |
ION™ Paclitaxel- Eluting Coronary Stent System (Monorail and Over-The-Wire Systems) | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the ION™ Paclitaxel- Eluting Coronary Stent System. This device is indicated 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 ≤ 34 mm in length. |
| P100029 4/20/11 |
St. Jude Medical Trifecta™ Valve | St. Jude Medical St. Paul, MN 55117 |
Approval for the St. Jude Medical Trifecta™ Valve. The Trifecta Valve is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve. |
| P100034 4/8/11 |
NovoTTF-100A System | NovoCure, Ltd. Rye Beach, NH 03871 |
Approval for the NovoTTF-100A System. The device is indicated for treatment of adult patients (22 years of age or older) with histologically- confirmed glioblastoma multiforme, following histologically- or radiologically- confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted. |
| P100040 4/1/11 |
Valiant® Thoracic Stent Graft with the Captivia Delivery System | Medtronic Vascular Santa Rosa, CA 95403 | Approval for the Valiant® Thoracic Stent Graft with the Captivia Delivery System. This device is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/ penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including: 1) iliac/femora access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; 2) non-aneurysmal aortic diameter in the range of 18-42 mm; and 3) non-aneurysmal aortic proximal and distal neck lengths ≥ 20 mm. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P840001/S159 4/22/11 180-Day |
Restore Family of Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for minor design changes to the L283 multi- function integrated circuit contained in the neurostimulators of the devices. |
| P840001/S178 4/4/11 Real-Time |
External Test Stimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for minor design, manufacturing, and labeling changes to the Model 3625 External Test Stimulator in order to establish compliance with functional requirements in the harmonized standards IEC (International Electrotechnical Commission) 60601-1 and IEC 60601-1-2. |
| P860003/S058 4/21/11 180-Day |
Therakos CELLEX Photopheresis System | Therakos, Inc. Raritan, NJ 08869 |
Approval for an additional sterilization site located at Sterigenics US LLC in Charlotte, North Carolina. |
| P880006/S070 4/4/11 180-Day |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical Sunnyvale, CA 94086 |
Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System. |
| P880086/S195 4/4/11 180-Day |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical Sunnyvale, CA 94086 |
Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System. |
| P890003/S169 4/4/11 180-Day |
CareLink Monitor, CardioSight® Reader and Device Data Management Application (DDMA) | Medtronic, Inc. Mounds View, MN 55112 | Approval for the Advisa™ DR A4DR01 Implantable Pulse Generator, Model 9995 Application Software v7.3, CareLink Monitor Model 2490G upgrade, CardioSight® Reader Model 2020A upgrade, and Model 2491 DDMA upgrade. |
| P890064/S026 4/20/11 Real-Time |
QIAGEN digene® Hybrid Capture 2 (HC2) HPV DNA Test QIAGEN digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test |
QIAGEN Gaithersburg Inc. Gaithersburg, MD 20878 |
Approval for software design change of the hc2 System Suite consisting of an hc2 system software upgrade from version 2.0 to version 3.0. |
| P910001/S042 4/20/11 135-Day |
ELCA Coronary Atherectomy Catheters | Spectranetics, Inc. Colorado Springs, CO 80921 |
Approval to implement the use of an automated method instead of a manual method of dispensing epoxy adhesive. |
| P910023/S253 4/25/11 135-Day |
Cadence ICDs | St. Jude Medical Sunnyvale, CA 94086 |
Approval for an alternate supplier for the RF antenna module. |
| P910023/S254 4/4/11 180-Day |
Cadence Family of ICDs | St. Jude Medical Sunnyvale, CA 94086 |
Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System. |
| P930027/S011 4/26/11 Real-Time |
IMMULITE®/ IMMULITE® 2000 PSA | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for introduction of a new instrument model IMMULITE® 2000 XPi Analyzer, as a family member of the currently cleared IMMULITE® 2000 Analyzer. |
| P950032/S063 4/6/11 Real-Time |
Apligraf (Graftskin) | Organogenesis, Inc. Canton, MA 02021 |
Approval for the introduction of keratinocyte cell strain (HEP071) into the manufacture of Apligraf. |
| P950037/S088 4/20/11 180-Day |
Reliaty Family of Pacing System Analyzers | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for: 1) new display screen; 2) alternate battery; 3) modified battery cartridge; 4) modified battery contacts; 5) new firmware; 6) updated software; 7) modified control knob; 8) modified circuit boards; and 9) Technical Manual and device labeling changes. |
| P950037/S089 4/15/11 180-Day |
Renamic Programmer and Software Version PSW 1004.U | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Renamic Programmer and Software Version PSW 1004.U. |
| P960009/S090 4/22/11 180-Day |
Activa Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for minor design changes to the L283 multi- function integrated circuit contained in the neurostimulators of the devices. |
| P960009/S108 4/4/11 Real-Time |
External Test Stimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for minor design, manufacturing, and labeling changes to the Model 3625 External Test Stimulator in order to establish compliance with functional requirements in the harmonized standards IEC (International Electrotechnical Commission) 60601-1 and IEC 60601-1-2. |
| P960040/S227 4/8/11 135-Day |
VITALITY Family of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of a receiving inspection step for setscrews on header components. |
| D970003/S122 4/8/11 135-Day |
INSIGNIA Pulse Generators |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of a receiving inspection step for setscrews on header components. |
| P970003/S124 4/19/11 135-Day |
VNS Therapy® System | Cyberonics, Inc. Houston, TX 77058 |
Revision to the test tab routing steps. |
| P970004/S104 4/4/11 Real-Time |
External Test Stimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for minor design, manufacturing, and labeling changes to the Model 3625 External Test Stimulator in order to establish compliance with functional requirements in the harmonized standards IEC (International Electrotechnical Commission) 60601-1 and IEC 60601-1-2. |
| P970013/S038 4/4/11 180-Day |
Microny Family of Pacemakers | St. Jude Medical Sunnyvale, CA 94086 |
Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System. |
| P970027/S013 4/15/11 180-Day |
AxSYM Anti-HCV | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland. |
| P970031/S032 4/15/11 Real-Time |
Freestyle Aortic Root Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for modifications to your secondary and tertiary packaging, including the addition of two new materials: a temperature indicator (to be placed in the secondary package) and a clear end seal label. |
| P970051/S068 4/7/11 Special |
Cochlear Nucleus 5 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for additional labeling for the CI500 Series Cochlear Implant. |
| P980003/S025 4/8/11 180-Day |
Chilli® Cooled Ablation System – Chilli® Tubing Kit | Boston Scientific Corporation San Jose, CA 95134 |
Approval for ten design changes to the CircuCool Model 8005 Pump System to address stoppage and motor noise complaints. These changes include: 1) Changing a Schotky diode from ON Semiconductor’s 1N5822 (40V maximum reverse voltage) to ON Semiconductor’s MBR360 (60V maximum reverse voltage); 2) Addition of a 33.3V voltage suppressor (ON Semiconductor P6KE39AG) across motor terminals at the motor; and 3) Dimensional and tolerance revisions to the roller sleeve, shaft rotor and roller components. |
| P980016/S187 4/4/11 180-Day |
Secura™ DR/VR D224DRG/D224VRC, Virtuoso II DR/VR D274DRG/ D274VRC and Maximo® II DR/VR D284DRG/ D284 VRC Implantable Cardioverter Defibrillators (ICDs) | Medtronic, Inc. Mounds View, MN 55112 | Approval for the Advisa™ DR A4DR01 Implantable Pulse Generator, Model 9995 Application Software v7.3, CareLink Monitor Model 2490G upgrade, CardioSight® Reader Model 2020A upgrade, and Model 2491 DDMA upgrade. |
| P980018/S013 4/18/11 Special |
HercepTest™ | Dako Denmark A/S Glostrup, Denmark |
Approval for labeling changes that add precaution and an instruction that is intended to enhance the safe use of HercepTest™. |
| P980024/S005 4/18/11 135-Day |
PathVysion™ HER-2 DNA Probe Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for the implementation of process changes to the manufacture of the PathVysion HER-2 DNA Probe Kit Assay, including a new FISH DNA extraction process, and RNA reduction step, new sonication equipment, and a new amination/ labeling procedure. |
| P980035/S134 4/4/11 180-Day |
Advisa™ DR A4DR01 Implantable Pulse Generator and Model 9995 Application Software v7.3 | Medtronic, Inc. Mounds View, MN 55112 | Approval for the Advisa™ DR A4DR01 Implantable Pulse Generator, Model 9995 Application Software v7.3, CareLink Monitor Model 2490G upgrade, CardioSight® Reader Model 2020A upgrade, and Model 2491 DDMA upgrade. |
| P980037/S035 4/7/11 Real-Time |
AngioJet® Rheolytic™ Thrombectomy System | MEDRAD Inverventional/ Possis Minneapolis, MN 55433 |
Approval for changes to the AngioJet Ultra XMI Thrombectomy Set TruSeal Introducer. |
| P980043/S030 4/15/11 Real-Time |
HANCOCK II Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for modifications to your secondary and tertiary packaging, including the addition of two new materials: a temperature indicator (to be placed in the secondary package) and a clear end seal label. |
| P990020/S043 4/12/11 135-Day |
AneuRx AAAdvantage Stent Graft with Xcelerant Hydro Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval to extend the scope of the receiving and manufacturing activities conducted at a third party storage location. |
| P990064/S037 4/15/11 Real-Time |
MOSAIC Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for modifications to your secondary and tertiary packaging, including the addition of two new materials: a temperature indicator (to be placed in the secondary package) and a clear end seal label. |
| P000009/S042 4/15/11 180-Day |
Renamic Programmer and Software Version PSW 1004.U | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Renamic Programmer and Software Version PSW 1004.U. |
| P000054/S027 4/4/11 135-Day |
INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for an additional source of recombinant insulin. |
| P000058/S040 4/4/11 135-Day |
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for an additional source of recombinant insulin. |
| P010007/S005 4/26/11 Real-Time |
IMMULITE®/ IMMULITE® 2000 AFP | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for introduction of a new instrument model IMMULITE® 2000 XPi Analyzer, as a family member of the currently cleared IMMULITE® 2000 Analyzer. |
| P010012/S247 4/8/11 135-Day |
CONTRAK RENEWAL TR2 and LIVIAN Families of CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of a receiving inspection step for setscrews on header components. |
| P010012/S264 4/7/11 Real-Time |
ACUITY Spiral Leads and Lead Stabilizer Accessory | Boston Scientific St. Paul, MN 55112 |
Approval for reassignment of a mechanical input specification, Suture Sleeve Resistance to Cut-Through from the suture sleeve, to the lead body for the ACUITY Spiral Implantable lead. |
| P010023/S004 4/8/11 180-Day |
Maxum System | Ototronix LLC St. Paul, MN 55110 |
Approval for the change to a digital processor in the external integrated processor and coil (IPC). The MAXUM Digital IPC replaces the analog processor with a standard commercial digital processor intended for hearing aid use. |
| P010030/S023 4/19/11 180-Day |
LifeVest Wearable Defibrillator WCD 4000 | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Approval for updated bare board artwork for use in the LifeVest Wearable Defibrillator WCD 4000. |
| P010031/S150 4/4/11 180-Day |
Consulta™ D224TRK, Concerto II D274TRK, an Maximo II D284TRK ICDs with Cardiac Resynchronization therapy (CRT-D) | Medtronic, Inc. Mounds View, MN 55112 | Approval for the Advisa™ DR A4DR01 Implantable Pulse Generator, Model 9995 Application Software v7.3, CareLink Monitor Model 2490G upgrade, CardioSight® Reader Model 2020A upgrade, and Model 2491 DDMA upgrade. |
| P010047/S009 4/13/11 180-Day |
Neomend Progel Pleural Air Leak Sealant | Neomend, Inc. Irvine, CA 92615 |
Approval for a manufacturing site located in Irvine, California. |
| P020009/S065 4/1/11 135-Day |
Express®/Express 2® Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the removal of the monthly ongoing product particulate testing at the Maple Grove manufacturing facilities. |
| P030005/S067 4/8/11 135-Day |
CONTRAK RENEWAL TR CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of a receiving inspection step for setscrews on header components. |
| P030009/S050 4/12/11 135-Day |
Driver and Micro-Driver Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 | Approval for a change to allow the removal of the in-process functional testing completed on the stents of Driver and Micro-Driver Coronary Stent Systems and Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems. |
| P030009/S051 4/12/11 135-Day |
Driver™, Micro-Driver, and Integrity Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Approval to extend the scope of the receiving and manufacturing activities conducted at a third party storage location. |
| P030016/S018 4/8/11 180-Day |
STAAR Surgical Implantable Collamer Lens (Visian ICL) | STAAR Surgical Company Monrovia, CA 91016 |
Approval for a labeling modification to reflect results from an Axial Length Post-Approval Study Protocol. |
| P030035/S075 4/4/11 180-Day |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical Sunnyvale, CA 94086 |
Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System. |
| P030050/S007 4/5/11 180-Day |
Sculptra® Aesthetic (injectable poly-L-lactic acid) | Sanofi Aventis, US LLC Bridgewater, NJ 08807 |
Approval of the post-approval study protocol. |
| P030054/S176 4/25/11 135-Day |
Epic HF CRT-Ds | St. Jude Medical Sunnyvale, CA 94086 |
Approval for an alternate supplier for the RF antenna module. |
| P030054/S177 4/4/11 180-Day |
Epic HF/Atlas+HF Family of CRT-Ds | St. Jude Medical Sunnyvale, CA 94086 |
Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System. |
| P040016/S059 4/1/11 135-Day |
VeriFLEX (Liberté) Bare Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the removal of the monthly ongoing product particulate testing at the Maple Grove manufacturing facilities. |
| P040021/S014 4/1/11 180-Day |
Biocor™ Standard Aortic Models, Biocor™ Standard Mitral Models, Biocor™ Supra Models, Epic™ Standard Aortic Models, Epic™ Standard Mitral Models, Epic™ Supra Models | St. Jude Medical St. Paul, Mn 55128 |
Approval for a manufacturing site located at St. Jude Medical in Alajuela, Croatia. |
| P040033/S019 4/1/11 180-Day |
Birmingham Hip Resurfacing System | Smith & Nephew Orthopaedics Memphis, TN 38116 |
Approval of the post-approval study protocol. |
| P040037/S033 4/20/11 135-Day |
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for changes to the sterilization process. |
| P040044/S037 4/5/11 Real-Time |
Mynx Cadence Vascular Closure Device | AccessClosure, Inc. (ACI) Mountain View, CA 94043 |
Approval for a minor design change to modify the advancer tube to incorporate a dual slit design at the proximal end of the advancer tube. The device, as modified, will be marketed under the trade name Mynx Cadence Vascular Closure Device and is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. |
| P040051/S002 4/22/11 180-Day |
Surpass Acetabular System | Stelkast Company McMurray, PA 15317 | Approval of the post-approval study protocol. |
| P050023/S039 4/15/11 180-Day |
Renamic Programmer and Software Version PSW 1004.U | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Renamic Programmer and Software Version PSW 1004.U. |
| P050040/S002 4/29/11 Real-Time |
SPOT-Light® HER2 CISH™ Kit | Life Technologies Corporation Frederick, MD 21704 |
Approval for changes in the product insert: 1) Manufacturing address change; 2) Copyright change from Invitrogen Corporation to Life Technologies. Invitrogen will remain the brand name and therefore is still included on the product insert and labeling; and an addition of literature references to the bibliography. |
| P050048/S004 4/25/11 180-Day |
MONOLISA™ Anti-HBs EIA | Bio-Rad Technologies Redmond, WA 98052 |
Approval for use of the MONOLISA Anti-HBs EIA on the EVOLIS Automated Microplate System, adding lithium heparin and sodium heparin to the list of acceptable plasma specimen types, a change in the dye color in the Cutoff Calibrator, revision to the specimen storage requirements, and modification of the storage instructions for the Working Conjugate. The device, as modified, will be marketed under the trade name MONOLISA™ Anti-HBs EIA and is indicated for the detection of antibody to hepatitis B surface antigen in human serum and EDTA, heparin, or citrated plasma. The assay results may be used as an aide in the determination of susceptibility of hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The MONOLISA™ Anti-HBs EIA is intended for manual use and with the Bio-Rad EVOLIS™ Automated Microplate System in the detection of antibody to hepatitis B surface antigen. |
| P050049/S006 4/15/11 180-Day |
AxSYM HBsAg/ Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland. |
| P050051/S005 4/4/11 180-Day |
ARCHITECT AUSAB | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland and a manufacturing site at Abbott Diagnostics Division, Murex Biotech Limited in Kent, United Kingdom. |
| P050051/S007 4/4/11 180-Day |
ARCHITECT AUSAB |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland. |
| P050053/S018 4/4/11 135-Day |
INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for an additional source of recombinant insulin. |
| P060003/S008 4/15/11 180-Day |
AxSYM AUSAB | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland. |
| P060005/S004 4/26/11 Real-Time |
IMMULITE®/ IMMULITE® 2000 Free PSA | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for introduction of a new instrument model IMMULITE® 2000 XPi Analyzer, as a family member of the currently cleared IMMULITE® 2000 Analyzer. |
| P060006/S014 4/1/11 135-Day |
Express® SD Renal Monorail® Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the removal of the monthly ongoing product particulate testing at the Maple Grove manufacturing facilities. |
| P060007/S004 4/4/11 180-Day |
ARCHITECT HBsAg and HBsAg Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland. |
| P060009/S004 4/15/11 180-Day |
AxSYM CORE-M 2.0 | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland. |
| P060012/S006 4/15/11 180-Day |
AxSYM Core 2.0 | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland. |
| P060012/S007 4/21/11 135-Day |
AxSYM CORE 2.0 | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a change of test method with a different assay for determining antibody to hepatitis B virus core antigen specific activity and allowing for use of High Titer IgG and Low Titer IgG in place of each other when their concentrations overlap. |
| P060022/S008 4/29/11 135-Day |
Akreos Posterior Chamber Intraocular Lens | Bausch & Lomb Aliso Viejo, CA 92656 | Approval to implement the proposed change to the bioburden testing for the Akreos Posterior Chamber Intraocular Lens. |
| P060033/S060 4/12/11 135-Day |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 | Approval for a change to allow the removal of the in-process functional testing completed on the stents of Driver and Micro-Driver Coronary Stent Systems and Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems. |
| P060033/S061 4/12/11 135-Day |
Medtronic Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Approval to extend the scope of the receiving and manufacturing activities conducted at a third party storage location. |
| P060033/S063 4/20/11 Real-Time |
Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a modification to the regulatory elution specification. The device, as modified, will be marketed under the trade name Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System and is indicated for improving luminal diameter. |
| P070007/S026 4/12/11 135-Day |
Talent™ Thoracic Stent Graft with the Xcelerant and Captivia Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval to extend the scope of the receiving and manufacturing activities conducted at a third party storage location. |
| P070008/S019 4/15/11 180-Day |
Renamic Programmer and Software Version PSW 1004.U | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Renamic Programmer and Software Version PSW 1004.U. |
| P070027/S025 4/19/11 180-Day |
Talent Abdominal Stent Graft System | Medtronic, Inc. Santa Rosa, CA 95403 |
Approval of the post-approval study protocol. |
| P070027/S027 4/12/11 135-Day |
Talent™ Abdominal Stent Graft with the Xcelerant Hydro Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval to extend the scope of the receiving and manufacturing activities conducted at a third party storage location. |
| P080006/S002 4/1/11 180-Day |
Attain Ability™ Plus Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Attain Ability™ Plus Model 4296 Lead. |
| P080006/S005 4/29/11 180-Day |
Attain Ability Left Ventricular Lead | Medtronic CRDM Mounds View, MN 55112 | Approval for a shelf life extension from 6 to 24 months. |
| P080032/S006 4/7/11 180-Day |
Alair® Bronchial Thermoplasty System | Boston Scientific Corporation Sunnyvale, CA 94089 |
Approval of the post-approval study protocol. |
| P090013/S006 4/15/11 135-Day |
Revo MRI SureScan Pacing System | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the relocation of a sterilizer system and an additional BPA supplier. |
| P100010/S002 4/1/11 Real-Time |
Arctic Front Cardiac CryoAblation Catheters | Medtronic CryoCath LP Pointe Claire, Quebec Canada 2AF282 |
Approval for a design modification of the thermocouple wire bonding to the guidewire lumen. |
| P100010/S004 4/8/11 Real-Time |
Arctic Front Cardiac CryoAblation Catheters | Medtronic CryoCath LP Pointe Claire, Quebec, Canada H9R 5Z8 |
Approval for a design modification of guide wire lumen materials. |
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 |
|---|---|---|---|
| N17679/S035 4/29/11 |
Tetrafilcon A | Cooper Vision, Inc. Pleasanton, CA 94588 | Changes in criteria for acceptance for water content from 5% to 2%, and revision to maximum specifications of lens material components and the specification for water content. |
| N18033/S054 4/7/11 |
VISTAKON (etafilcon A) Contact Lenses, Clear and Visibly Tinted with UV Blocker | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Change in the sampling frequency of an in-process quality audit. |
| P810002/S073 4/8/11 |
St. Jude Mechanical Heart Valves | St. Jude Medical St. Paul, MN 55117 |
Revised steam sterilization load configuration. |
| P830037/S052 4/21/11 |
FreshLook (phemfilcon A) Soft Contact Lenses for Extended Wear | CIBA VISION Corporation Duluth, GA 30097 |
Upgrading the control system in the Finn Aqua Sterilizer FA5. |
| P830060/S068 4/29/11 |
VENTAK Family of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P840068/S049 4/29/11 |
DELTA and VISTA Families of Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P890003/S217 4/6/11 |
CareLink Remote Home Monitor and CardioSight Reader | Medtronic, Inc. Mounds View, MN 55112 |
The transfer of final device packaging inspection activities. |
| P890061/S019 4/29/11 |
VENTAK P Family of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P910073/S095 4/29/11 |
ENDOTAK RELIANCE Leads | Boston Scientific Corporation –CRM St. Paul, MN 55112 |
Make BSC the primary supplier of the 4-SITE lead terminal assembly. |
| P910073/S096 4/29/11 |
ENDOTAK Family of Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P910077/S112 4/29/11 |
Latitude™ Communicator | Boston Scientific Corporation St. Paul, MN 55112 |
Rework of Printed Circuit Assemblies (PCAs) used in the manufacture of the Latitude™ Communicator. |
| P910077/S113 4/29/11 |
VENTAK PRx/MINI Families of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P930035/S020 4/29/11 |
VENTAK P2 Family of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P930038/S066 4/8/11 |
Angio-Seal Vascular Closure Device | St. Jude Medical St. Paul, MN 55117 |
Elimination of a component cleaning. |
| P940008/S027 4/29/11 |
RES-Q and RES-Q MICRON Families of Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P940031/S071 4/29/11 |
VIGOR DR/SR, DISCOVERY, and MERIDIAN Families of Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P950001/S022 4/29/11 |
SELUTE Lead Family | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P950005/S034 4/6/11 |
Celsius, RMT, EZ Steer, EZ Steer DS Non-Temperature Sensing Ablation Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of a second qualified chamber for the sterilization process. |
| P950029/S058 4/8/11 |
REPLY SR/DR and ESPRIT SR/DR Implantable Cardiac Pacemakers | Sorin CRM, Inc. Plymouth, MN 55441 |
Update to the electronic hybrid module cleaning process. |
| P950037/S094 4/6/11 |
Evia DR, DR-T, SR and SR-T, Entovis DR, DR-T, SR and SR-T, Estella DR, DR-T, SR and SR-T, Ecuro DR, DR-T, SR and SR-T and Effecta D, DR, S and SR | Biotronik, Inc. Lake Oswego, OR 97035 |
New supplier site for the manufacture of electrical modules. |
| P960004/S049 4/29/11 |
THINLINE/ FINELINE Families of Leads |
Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P960006/S030 4/29/11 |
SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND Families of Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P960009/S113 4/29/11 |
Activa® Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of manufacturing changes for Activa® devices. |
| P960011/S019 4/1/11 |
BV1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 |
Alternate rheometer for testing in-process control and finished product samples. |
| P960013/S064 4/6/11 |
1782 Tendril Leads | St. Jude Medical, Inc. Sylmar, CA 91342 |
Addition of an alternate supplier for the connector ring crimp core. |
| P960040/S243 4/29/11 |
VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT and LIVIAN Families of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P970003/S125 4/29/11 |
VNS Therapy® System | Cyberonics, Inc. Houston, TX 77058 |
Modification of visual inspection acceptance criteria for three capacitors. |
| D970003/S127 4/29/11 |
Pulsar, Pulsar Max, Insignia, and Altrua Families of Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P970008/S056 4/29/11 |
Urologix Targis System for the Treatment of BPH | Urologix, Inc. Minneapolis, MN 55447 |
Changes in the quality control testing. |
| P970020/S062 4/8/11 |
MULTI-LINK ZETA® Coronary Stent System | Abbott Vascular, Inc. Temecula, CA 92591 |
Change in extruded tubing length, and a change from a manual tube cutting process to an automated process. |
| P970021/S034 4/5/11 |
GYNECARE THERMACHOICE III Uterine Balloon Therapy System | ETHICON, Women’s Health and Urology Somerville, NJ 08876 |
Manufacturing location change of a raw material supplier. |
| P970037/S005 4/8/11 |
AutoDELFIA® hAFP | PerkinElmer, Inc. Indianapolis, IN 46236 |
Change in a raw material used in the manufacture of the Enhancement Solution auxiliary reagent used with the AutoDELFIA hAFP kit. |
| P980035/S208 4/4/11 |
Adapta, Versa, Sensia, Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Upgrades to test system hardware and software. |
| P990025/S028 4/6/11 |
NaviStar, RMT, EZ Steer Nav, Qwikstar Interface Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of a second qualified chamber for the sterilization process. |
| P990071/S012 4/6/11 |
Interface Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of a second qualified chamber for the sterilization process. |
| P000039/S041 4/8/11 |
AMPLATZER® Septal Occluder | AGA Medical Corporation Plymouth, MN 55442 |
Modifications to pouch sealing equipment. |
| P010012/S266 4/29/11 |
CONTAK CD, LIVIAN, and COGNIS Families of CRT-Ds and EASYTRAK and ACUITY SPIRAL Families of Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P010013/S034 4/8/11 |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Implementation of a microbiology laboratory. |
| P010029/S012 4/1/11 |
EUFLEXXA® (1% Sodium Hyaluronate) |
Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 |
Alternate rheometer for testing in-process control and finished product samples. |
| P010068/S024 4/6/11 |
EZ Steer Nav DS and Qwikstar DS Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of a second qualified chamber for the sterilization process. |
| P020004/S061 4/8/11 |
GORE EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
Automation of the trimming process during the trunk wrapping and forming step. |
| P020024/S033 4/8/11 |
AMPLATZER® Duct Occluder | AGA Medical Corporation Plymouth, MN 55442 |
Modifications to pouch sealing equipment. |
| P020045/S036 4/29/11 |
Universal CryoConsole | Medtronic, Inc. Mounds View, MN 55112 | Addition of an additional calibration, calibration equipment, and associated documentation change. |
| P020045/S038 4/29/11 |
Freezor, Freezor Xtra, Freezor Max Cryoablation Catheters | Medtronic CryoCath LP Pointe Claire, Quebec, Canada |
Transfer the gas filling and testing operations for the compressor subassembly to the supplier. |
| P020047/S033 4/8/11 |
MULTI-LINK VISION® and MULTI-LINK MINI-VISION® OTW and RX Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Change in extruded tubing length, and a change from a manual tube cutting process to an automated process. |
| P030005/S074 4/29/11 |
CONTAK RENEWAL TR Family of CRT-Ps | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P030026/S021 4/22/11 |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator | Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 |
Change in the manufacturing scale of a reagent component. |
| P030031/S032 4/6/11 |
Celsius ThermoCool, Celsius RMT ThermoCool, NaviStar, NaviStar RMT, EZ Steer, EZ Steer Nav Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of a second qualified chamber for the sterilization process. |
| P030052/S005 4/8/11 |
UroVysion Bladder Cancer Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Changes to the reference DNA manufacturing and the small scale fermentation processes. |
| P040036/S023 4/6/11 |
Celsius, ThermoCool, Celsius RMT ThermoCool, NaviStar, NaviStar RMT, EZ Steer, EZ Steer Nav Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of a second qualified chamber for the sterilization process. |
| P040040/S018 4/8/11 |
AMPLATZER® Muscular VSD Occluder | AGA Medical Corporation Plymouth, MN 55442 |
Modifications to pouch sealing equipment. |
| P050018/S013 4/8/11 |
AngioSculpt® PTCA Scoring Balloon Catheter, Easy Exchange | Angioscore, Inc. Fremont, CA 94538 |
Addition of an inflation lumen inspection. |
| P050046/S010 4/29/11 |
ACUITY Steerable Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Change in biological indicator model used as part of the manufacturing process. |
| P060007/S012 4/21/11 |
ARCHITECT HBsAg and ARCHITECT HBsAg Confirmatory Assays | Abbott Laboratories Abbott Park, IL 60064 |
Test method conversions, raw material and vendor changes. |
| P060009/S005 4/4/11 |
AxSYM CORE-M 2.0 | Abbott Laboratories Abbott Park, IL 60064 | Changes to replace reagents for in- process testing of the HBV core antigen (anti-HBc) specific activity and to allow the use of two alternative precursors for manufacturing of the Purified Filtered HBc IgG within the Abbott Park, Illinois manufacturing facility. |
| P060031/S005 4/28/11 |
Bio-Rad MONOLISA™ Anti-HBc EIA | Bio-Rad Laboratories, Inc. Redmond, WA 98052 |
Change in the scale of manufacture of the Conjugate reagent component of the Bio-Rad MONOLISA™ Anti-HBc EIA. |
| P070015/S061 4/8/11 |
XIENCE V® and PROMUS Everolimus Eluting Coronary Stent System | Abbott Vascular, Inc. Temecula, CA 92591 |
Change in extruded tubing length, and a change from a manual tube cutting process to an automated process. |
| P070015/S062 4/8/11 |
XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 |
Remove redundant cleaning and treatment steps. |
| P070015/S063 4/8/11 |
XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 |
Modification of cleanroom classification and gowning requirements. |
| P070015/S065 4/29/11 |
XIENCE® and PROMUS Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Extension of shelf life and retest date of an intermediate component. |
| P070015/S066 4/29/11 |
XIENCE V® Eluting Coronary Stent System and PROMUS™ Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Modification of a sampling plan for particulate testing. |
| P070022/S016 4/14/11 |
Adiana Permanent Contraception System | Hologic, Inc. Marlborough, MA 01752 |
Change in inspection procedure. |
| P070022/S017 4/8/11 |
Adiana Permanent Contraception System | Hologic, Inc. Marlborough, MA 01752 |
Implementation of a microbiology laboratory. |
| P080004/S006 4/7/11 |
Hoya iSpheric Intraocular Lens | Hoya Surgical Optics, Inc. Chino Hills, CA 91709 |
Changes to the previously approved test laboratory and to the LAL test method. |
| P100010/S009 4/29/11 |
Balloon Catheter | Medtronic CryoCath LP Pointe Claire, Quebec, Canada |
Transfer the gas filling and testing operations for the compressor subassembly to the supplier. |
Summary of PMA Originals & Supplements Approved
Originals: 6
Supplements: 85
Summary of PMA Originals Under Review
Total Under Review: 100
Total Active: 49
Total On Hold: 51
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 725
Total Active: 539
Total On Hold: 186
Number Greater Than 180 Days: 11
Summary of All PMA Submissions Received
Originals: 10
Supplements: 55
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 85
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 175.8
FDA Time: 104.2 Days MFR Time: 71.6 Days
