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PMA Final Decisions for April 2011

Posted Jun 06 2011 12:00am

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P100018
4/6/11
Pipeline™ Embolization Deviceev3, 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 TestRoche 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™ ValveSt. 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 SystemNovoCure, 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 SystemMedtronic Vascular Santa Rosa, CA 95403Approval 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.
APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P840001/S159
4/22/11
180-Day
Restore Family of NeurostimulatorsMedtronic Neuromodulation Minneapolis, MN 55432Approval 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 StimulatorMedtronic 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 SystemTherakos, 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 PacemakersSt. 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 PacemakersSt. 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 55112Approval 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 CathetersSpectranetics, 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 ICDsSt. 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 ICDsSt. 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 PSASiemens 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 AnalyzersBiotronik, 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.UBiotronik, 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 NeurostimulatorsMedtronic Neuromodulation Minneapolis, MN 55432Approval 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 StimulatorMedtronic 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 ICDsBoston 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® SystemCyberonics, Inc.
Houston, TX
77058
Revision to the test tab routing steps.
P970004/S104
4/4/11
Real-Time
External Test StimulatorMedtronic 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 PacemakersSt. 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-HCVAbbott 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 BioprosthesisMedtronic, 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 SystemCochlear 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 KitBoston 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 55112Approval 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 KitAbbott 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 v7.3Medtronic, Inc. Mounds View, MN 55112Approval 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 SystemMEDRAD 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 BioprosthesisMedtronic, 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 SystemMedtronic 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 BioprosthesisMedtronic, 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.UBiotronik, 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 GraftMedtronic 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 FusionMedtronic Sofamor Danek
Memphis, TN
38132
Approval for an additional source of recombinant insulin.
P010007/S005
4/26/11
Real-Time
IMMULITE®/ IMMULITE® 2000 AFPSiemens 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-DsBoston 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 AccessoryBoston 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 SystemOtotronix 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 4000Zoll 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 55112Approval 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 SealantNeomend, 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 SystemBoston 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-DsBoston 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 SystemsMedtronic Vascular Santa Rosa, CA 95403Approval 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 SystemsMedtronic 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-PsSt. 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-DsSt. 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-DsSt. 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 SystemBoston 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 ModelsSt. 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 SystemSmith & 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 SurfaceW.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 DeviceAccessClosure, 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 SystemStelkast Company McMurray, PA 15317Approval of the post-approval study protocol.
P050023/S039
4/15/11
180-Day
Renamic Programmer and Software Version PSW 1004.UBiotronik, 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™ KitLife 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 EIABio-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/ ConfirmatoryAbbott 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 AUSABAbbott 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 GraftMedtronic Sofamor Danek
Memphis, TN
38132
Approval for an additional source of recombinant insulin.
P060003/S008
4/15/11
180-Day
AxSYM AUSABAbbott 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 PSASiemens 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 SystemBoston 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 ConfirmatoryAbbott 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 2.0Abbott 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 2.0Abbott 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 2.0Abbott 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 LensBausch & Lomb Aliso Viejo, CA 92656Approval 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 SystemsMedtronic Vascular Santa Rosa, CA 95403Approval 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 SystemsMedtronic 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 SystemMedtronic 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 SystemMedtronic 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.UBiotronik, 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 SystemMedtronic, 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 SystemMedtronic 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 LeadMedtronic, 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 LeadMedtronic CRDM Mounds View, MN 55112Approval for a shelf life extension from 6 to 24 months.
P080032/S006
4/7/11
180-Day
Alair® Bronchial Thermoplasty SystemBoston Scientific Corporation
Sunnyvale, CA
94089
Approval of the post-approval study protocol.
P090013/S006
4/15/11
135-Day
Revo MRI SureScan Pacing SystemMedtronic, 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 CathetersMedtronic 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 CathetersMedtronic CryoCath LP
Pointe Claire, Quebec, Canada
H9R 5Z8
Approval for a design modification of guide wire lumen materials.
APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N17679/S035
4/29/11
Tetrafilcon ACooper Vision, Inc. Pleasanton, CA 94588Changes 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 BlockerJohnson & 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 ValvesSt. Jude Medical
St. Paul, MN
55117
Revised steam sterilization load configuration.
P830037/S052
4/21/11
FreshLook (phemfilcon A) Soft Contact Lenses for Extended WearCIBA VISION Corporation
Duluth, GA
30097
Upgrading the control system in the Finn Aqua Sterilizer FA5.
P830060/S068
4/29/11
VENTAK Family of ICDsBoston 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 PacemakersBoston 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 ReaderMedtronic, Inc.
Mounds View, MN
55112
The transfer of final device packaging inspection activities.
P890061/S019
4/29/11
VENTAK P Family of ICDsBoston 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 LeadsBoston 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 LeadsBoston Scientific Corporation
St. Paul, MN
55112
Change in biological indicator model used as part of the manufacturing process.
P910077/S112
4/29/11
Latitude™ CommunicatorBoston 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 ICDsBoston 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 ICDsBoston 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 DeviceSt. Jude Medical
St. Paul, MN
55117
Elimination of a component cleaning.
P940008/S027
4/29/11
RES-Q and RES-Q MICRON Families of LeadsBoston 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 PacemakersBoston 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 FamilyBoston 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 CathetersBiosense 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 PacemakersSorin 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 SRBiotronik, 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 LeadsBoston 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 NeurostimulatorsMedtronic 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 LeadsSt. 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 ICDsBoston 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® SystemCyberonics, 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 PacemakersBoston 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 BPHUrologix, Inc.
Minneapolis, MN 55447
Changes in the quality control testing.
P970020/S062
4/8/11
MULTI-LINK ZETA® Coronary Stent SystemAbbott 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 SystemETHICON, Women’s Health and Urology
Somerville, NJ
08876
Manufacturing location change of a raw material supplier.
P970037/S005
4/8/11
AutoDELFIA® hAFPPerkinElmer, 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 IPGsMedtronic, Inc.
Mounds View, MN 55112
Upgrades to test system hardware and software.
P990025/S028
4/6/11
NaviStar, RMT, EZ Steer Nav, Qwikstar Interface CablesBiosense Webster, Inc.
Diamond Bar, CA
91765
Addition of a second qualified chamber for the sterilization process.
P990071/S012
4/6/11
Interface CablesBiosense Webster, Inc.
Diamond Bar, CA
91765
Addition of a second qualified chamber for the sterilization process.
P000039/S041
4/8/11
AMPLATZER® Septal OccluderAGA 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 LeadsBoston 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 SystemHologic, 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 CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Addition of a second qualified chamber for the sterilization process.
P020004/S061
4/8/11
GORE EXCLUDER® AAA EndoprosthesisW.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 OccluderAGA Medical Corporation
Plymouth, MN
55442
Modifications to pouch sealing equipment.
P020045/S036
4/29/11
Universal CryoConsoleMedtronic, Inc. Mounds View, MN 55112Addition of an additional calibration, calibration equipment, and associated documentation change.
P020045/S038
4/29/11
Freezor, Freezor Xtra, Freezor Max Cryoablation CathetersMedtronic 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 SystemsAbbott 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-PsBoston 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 CalibratorOrtho 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 CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Addition of a second qualified chamber for the sterilization process.
P030052/S005
4/8/11
UroVysion Bladder Cancer KitAbbott 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 CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Addition of a second qualified chamber for the sterilization process.
P040040/S018
4/8/11
AMPLATZER® Muscular VSD OccluderAGA Medical Corporation
Plymouth, MN
55442
Modifications to pouch sealing equipment.
P050018/S013
4/8/11
AngioSculpt® PTCA Scoring Balloon Catheter, Easy ExchangeAngioscore, Inc.
Fremont, CA
94538
Addition of an inflation lumen inspection.
P050046/S010
4/29/11
ACUITY Steerable LeadsBoston 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 AssaysAbbott Laboratories
Abbott Park, IL
60064
Test method conversions, raw material and vendor changes.
P060009/S005
4/4/11
AxSYM CORE-M 2.0Abbott Laboratories Abbott Park, IL 60064Changes 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 EIABio-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 SystemAbbott 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 SystemsAbbott Vascular
Temecula, CA
92591
Remove redundant cleaning and treatment steps.
P070015/S063
4/8/11
XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent SystemsAbbott Vascular
Temecula, CA
92591
Modification of cleanroom classification and gowning requirements.
P070015/S065
4/29/11
XIENCE® and PROMUS Everolimus Eluting Coronary Stent SystemAbbott 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 SystemAbbott Vascular Temecula, CA
92591
Modification of a sampling plan for particulate testing.
P070022/S016
4/14/11
Adiana Permanent Contraception SystemHologic, Inc.
Marlborough, MA 01752
Change in inspection procedure.
P070022/S017
4/8/11
Adiana Permanent Contraception SystemHologic, Inc.
Marlborough, MA
01752
Implementation of a microbiology laboratory.
P080004/S006
4/7/11
Hoya iSpheric Intraocular LensHoya 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 CatheterMedtronic 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

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