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PMA Final Decisions for October 2012

Wed, 12/26/2012 - 12:00am
U.S. Food & Drug Administration

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.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P100012
10/26/12
PCM® Cervical Disc System NuVasive, Incorporated
San Diego, CA
92121
Approval for the PCM Cervical Disc System. This device is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The PCM Cervical Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the PCM Cervical Disc.
P110008
10/17/12
coflex® Interlaminar Technology Paradigm Spine, LLC
New York, NY
10022
Approval for the coflex ® Interlaminar Technology. This device is indicated for use in one- or two-level lumbar stenosis from L1- L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 month of non-operative treatment. The coflex is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).
P110021
10/19/12
Edwards SAPIEN™ Transcatheter Heart Valve (Model 9000TFX, sizes 23mm and 26mm) with RetroFlex 3 Delivery System (Models 9120FS23 and 9120FS26), Edwards SAPIEN™ Transcatheter Heart Valve with Ascendra Delivery System (Models 9100BCL23 and 9100BCL26), and accessories (RetroFlex™ Balloon Catheter, Models 9120BC20 and 9120BC23; Ascendra™ Balloon Aortic Valvuloplasty Catheter, Model 9100BAVC; AscendraTM Introducer Sheath Set Model 9100IS; and Crimper, Models 9100CR23 and 9100CR26) Edwards Lifesciences LLC
Irvine, CA
92614
Approval for Edwards
SAPIEN™ Transcatheter Heart Valve Model 9000TFX, sizes 23mm and 26mm, and Transapical and Transfemoral Accessories listed above. This device is indicated for the following:
Transapical - The Edwards SAPIEN transcatheter heart valve, model 9000TFX, sizes 23 mm and 26 mm, is indicated for transapical delivery in patients with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction > 20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons operative risk score ≥ 8% or are judged by the heart team to be at a ≥15% risk of mortality for surgical aortic valve replacement. The Ascendra Balloon Catheter is indicated for the transapica1 delivery of the Edwards SAPIEN transcatheter heart valve. Transfemoral The Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX, sizes 23 mm and 26 mm, is indicated for transfemoral delivery in patients with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction >20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to either be: 1) inoperable and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis; or 2) be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons predicted operative risk score ≥ 8% or are judged by the heart team to be at a ≥15% risk of mortality for surgical aortic valve replacement. The RetroFlex 3 Delivery System is indicated for the transfemoral delivery of the Edwards SAPIEN transcatheter heart valve.
P110039
10/18/12
InSightec ExAblate® System, Model 2000/2100/ 2100 VI InSightec, Incorporation
Dallas, TX
75244
Approval for the ExAblate System, Model 2000/2100/ 2100 VI. This device is indicated for pain palliation of Metastatic Bone Cancer in patients 18 years of age or older who are suffering from bone pain due to metastatic disease and who arc failures of standard radiation therapy, or not candidates for, or refused radiation therapy. The bone tumor to be treated must be visible on non-contrast MR and device accessible.
P120005
10/5/12
Dexcom G4 PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA
92121
Approval for the Dexcom G4 PLATINUM Continuous Glucose Monitoring System. This device is indicated for:
The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription.
The Dexcom G4 PLATINUM System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.
The Dexcom G4 PLATINUM System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G4 PLATINUM System results should be based on the trends and patterns seen with several sequential readings over time.
P120006
10/5/12
Ovation Abdominal Stent Graft System TriVascular, Inc.
Santa Rosa, CA
95403
Approval for the Ovation Abdominal Stent Graft System. This device is indicated for treatment of patients with abdominal aortic aneurysms having vascular morphology suitable for endovascular repair, including:
1) Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories;
2) Non-aneurysmal proximal aortic neck: a) with a length of at least 7 mm proximal to the aneurysm; b) with an inner wall diameter of no less than 16 mm and no greater than 30 mm; and c) with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is ≤10 mm.
3) Adequate distal iliac landing zone:
a) with a length of at least 10 mm; and with an inner wall diameter of no less than 8 mm and no greater than 20 mm.
P120007
10/12/12
APTIMA® HPV 16 18/45 Genotype Assay Gen-Probe Incorporated
San Diego, CA
92121
Approval for the APTIMA HPV 16 18/45 Genotype Assay.
APTIMA HPV 16 18/45 Genotype Assay Indications for Use: The APTIMA HPV 16 18/45 Genotype Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18, and 45 in cervical specimens from women with APTIMA HPV Assay positive results. The APTIMA HPV 16 18/45 Genotype Assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the APTIMA HPV 16 18/45 Genotype Assay. The assay is used with the TIGRIS DTS System. The use of the test is indicated:
1) In patients 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, the APTIMA HPV 16 18/45 Genotype Assay can be used to test samples from women with APTIMA HPV Assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. 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; and
2) In women 30 years and older, the APTIMA HPV 16 18/45 Genotype Assay can be used to test samples from women with APTIMA HPV Assay positive results. The assay results wi11 be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
* Broom-type device (e.g., Wallach Pipette), or endocervical brush/spatula.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P830060/S072
10/5/12
Real-Time
VENTAK Automatic Implantable Cardioverter Defibrillator (AICD) System Family Boston Scientific Corporation, CRM
St. Paul, MN
55112
Approval for the use of a longer sterile barrier Tyvek pouch as primary packaging for the BSC CRV leads accessory products.
P830061/S064
10/4/12
180-Day
CapSure Sense Bipolar Lead Medtronic, Inc.
Mounds View, MN
55112
Approval for a manufacturing site located at Medtronic Singapore Pte. Ltd., in Singapore.
P870025/S011
10/10/12
Special
 
Corometrics Fetal Acoustic Stimulator (FAST) Wipro GE Healthcare
Laurel, MD
20723
Approval for changes made to the labeling to comply with IEC 60601-1:2005, 3 rd Edition.
P870076/S013
10/26/12
Special
Falope-Ring Band and Applicator Systems Gyrus ACMI, Inc.
Southborough, MA
01772
Approval for labeling changes including adding/ modifying warnings in the instruction for use, updating company branding, and separating the Quick Reference Guides for the reusable and disposable applicators.
P890055/S043
10/16/12
Real-Time
MedStream Programmable Infusion System Codman & Shurtleff, Incorporated
Raynham, MA
02767
Approval for a modification to the Programmable Infusion System. This modification consisted of removal of the epoxy used on the wires of the actuator component of the Pump.
P890055/S045
10/12/12
Real-Time
MedStream Programmable Infusion System Codman & Shurtleff, Incorporated
Raynham, MA
02767
Approval to add Gablofen intrathecal to the list of approved drugs in the instructions for use. The device, as modified, will be marketed under the trade name MedStream Programmable Infusion System and is indicated for chronic intrathecal infusion of baclofen injection sterile solution in the treatment of severe spasticity.
P890055/S046
10/26/12
Real-Time
MedStream Implantable Infusion System Codman & Shurtfleff, Incorporated
Raynham, MA
02767
Approval for a packaging modification to the device.
P910056/S013
10/19/12
Real-Time
enVista® Hydrophobic Acrylic Intraocular Lens Bausch & Lomb, Incorporated
Aliso Viejo, CA
92656
Approval for changes to the directions for use (DFU) to specify that the enVista® MX60 Lens is approved for use with the Medicel Accuject 2.2 (Rev. 1) injector set,or other injector sets that specifically identify the enVista® MX60 lens in the cleared labeling.
P910073/S105
10/5/12
Real-Time
Transvenous Defibrillation Lead; Accessory Stylets Boston Scientific Corporation, CRM
St. Paul, MN
55112
Approval for the use of a longer sterile barrier Tyvek pouch as primary packaging for the BSC CRV leads accessory products.
P910077/S122
10/5/12
Real-Time
VENTAK PRx and VENTAK MINI AICD Families Boston Scientific Corporation, CRM
St. Paul, MN
55112
Approval for the use of a longer sterile barrier Tyvek pouch as primary packaging for the BSC CRV leads accessory products.
P930035/S022
10/5/12
Real-Time
VENTAK P/P2 AICD System Families Boston Scientific Corporation, CRM
St. Paul, MN
55112
Approval for the use of a longer sterile barrier Tyvek pouch as primary packaging for the BSC CRV leads accessory products.
P930036/S005
10/15/12
180-Day
ADVIA Centaur® AFP Assay Siemens Healthcare Diagnostics, Inc.
Walpole, MA
02032
Approval for a manufacturing site located at STRATEC Biomedical Switzerland AG in Beringen, Switzerland.
P930039/S072
10/4/12
180-Day
CapSureFix Novus Leads Medtronic, Inc.
Mounds View, MN
55112
Approval for a manufacturing site located at Medtronic Singapore Operation Pte, in Singapore.
P950021/S013
10/15/12
180-Day
ADVIA Centaur® PSA Assay Siemens Healthcare Diagnostics, Inc.
Walpole, MA
02032
Approval for a manufacturing site located at STRATEC Biomedical Switzerland AG in Beringen, Switzerland.
P950022/S083
10/16/12
Real-Time
Durata Lead Models St. Jude Medical
Sylmar, CA
91342
Approval for changes to the packaging of the Quartet IS4 and Durata DF4 leads.
P950037/S105
10/3/12
180-Day
Programmer Software PSW Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Evia HF/HF-T family of CRT-Ps and new programmer software identified as 1203.U/1.
P960004/S054
10/5/12
Real-Time
Active Fixation Transvenous Bipolar Pacing Lead Boston Scientific Corporation, CRM
St. Paul, MN
55112
Approval for the use of a longer sterile barrier Tyvek pouch as primary packaging for the BSC CRV leads accessory products.
P960040/S265
10/5/12
Real-Time
 
VENTAK AV and PRIZM DR/VR, VITALITY, CONFIENT and Teligen AICD Boston Scientific Corporation, CRM
St. Paul, MN
55112
Approval for the use of a longer sterile barrier Tyvek pouch as primary packaging for the BSC CRV leads accessory products.
P960042/S042
10/31/12
Special
Spectranetics Laser Sheath (SLS) II and Glidelight Laser Sheath Spectranetics Corporation
Colorado Springs, CO
80921
Approval for modifying the SLS II and GlideLight Instruction for Use Manuals to include a warning and precaution statement and strengthen a warning.
P980016/S376
10/26/12
180-Day
EnTrust ICD; GEM II DR ICD; GEM II VR ICD; GEM III DR ICD; GEM III VR ICD; Intrinsic 30 ICD; Intrinsic ICD; Marquis DR ICD; Marquis VR ICD; Maximo II ICD; Protecta ICD; Protecta XT ICD; Secura ICD; Virtuoso ICD; and
Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic ICD Longevity Estimation Tool (MILET) to be used by Medtronic personnel for the devices.
P980022/S123
10/26/12
Real-Time
Guardian® REAL-Time System Medtronic, Inc.
Northridge, CA
91325
Approval for minor software modifications in Guardian® REAL-Time System to optimize the shutdown procedure for the Guardian Monitor and to correct an anomaly that allowed access of out-of-bounds pointer errors.
P980035/S223
10/4/12
180-Day
Adapta/Versa/ Sensia Implantable Pulse Generator Medtronic, Inc.
Mounds View, MN
55112
Approval for a manufacturing site located at Medtronic Singapore Pte Ltd., in Singapore.
P980035/S252
10/3/12
135-Day
Adapta, Relia, Sensia and Versa IPGs Medtronic, Inc.
Mounds View, MN
55112
Approval for revisions to a test program used in the manufacture of integrated circuits.
P980037/S040
10/16/12
Real-Time
AngioJet® Rheolytic Thrombectomy System MEDRAD Interventional
Minneapolis, MN
55433
Approval for changing the packaging tray material for the AngioJet Ultra XMI, Ultra Spiroflex, and Ultra Spiroflex VG Thrombectomy Sets from PETG to PETG Denest, as well as changing the manufacturing of these packaging trays from PerfecSeal To Brookdale.
P980050/S076
10/26/12
180-Day
GEM III AT Medtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic ICD Longevity Estimation Tool (MILET) to be used by Medtronic personnel for the devices.
P990055/S014
10/15/12
180-Day
ADVIA Centaur® cPSA Assay Siemens Healthcare Diagnostics, Inc.
Walpole, MA
02032
Approval for a manufacturing site located at STRATEC Biomedical Switzerland AG in Beringen, Switzerland.
P990071/S016
10/31/12
180-Day
SmartAblate™ Irrigation Pump and SmartAblate™ Tubing Set Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for upgrading the existing accessory Coolflow™ Irrigation Pump for the STOCKERT 70 Radiofrequency (RF) Generator for Cardiac Ablation. The device, as modified, will be marketed under the trade name SmartAblate™ Irrigation Pump and SmartAblate™ Tubing Set. The indications are that the SmartAblate™ Irrigation Pump is a peristaltic pump designed to work in conjunction with the STOCKERT 70 Radiofrequency Generator to deliver irrigation solution at specified now rates to irrigated catheters (such as the Biosense Webster Celsius® ThermoCool® Catheters and NaviStar® ThermoCool® Catheters) for cooling purposes. The pump is used with the SmartAblate™ Irrigation Tubing Set that conducts the irrigation solution from an external source to the compatible irrigated catheters.
P000009/S049
10/3/12
180-Day
Programmer Software PSW Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Evia HF/HF-T family of CRT-Ps and new programmer software identified as 1203.U/1.
P000025/S062
10/26/12
180-Day
MED-EL COMBI 40+ Cochlear Implant System, RONDO Audio Processor MED-EL Corporation
Durham, NC
27713
Approval for the RONDO audio processor.
P000054/S031
10/17/12
135-Day
INFUSE Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for change in resin usage lifetime.
P000054/S035
10/25/12
135-Day
INFUSE® Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for the extension of the expiry of batch reference material.
P000058/S044
10/17/12
135-Day
INFUSE Bone Graft/LT-Cage Lumbar Tapered Fusion Medtronic Sofamor Danek
Memphis, TN
38132
Approval for change in resin usage lifetime.
P000058/S050
10/25/12
135-Day
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Medtronic Sofamor Danek
Memphis, TN
38132
Approval for the extension of the expiry of batch reference material.
P010012/S295
10/5/12
Real-Time
CONTAK CD, EASYTRAK, LIVIAN, COGNIS and ACUITY SPIRAL Families Boston Scientific Corporation, CRM
St. Paul, MN
55112
Approval for the use of a longer sterile barrier Tyvek pouch as primary packaging for the BSC CRV leads accessory products.
P010031/S329
10/26/12
180-Day
Concerto ICD; Concerto II CRT-D;
Consulta DF4 ICD; InSync II Protect ICD; InSync III
Marquis ICD; InSync Maximo ICD; InSync Sentry; InSync II Marquis;
InSync Marquis;
Maximo II CRT-D; Protecta CRT-D; and Protecta XT CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic ICD Longevity Estimation Tool (MILET) to be used by Medtronic personnel for the devices.
P010032/S055
10/25/12
135-Day
Eon Mini Neuromodulation System St. Jude Medical
Plano, TX
75024
Approval for the addition of stand-off tabs on the routed printed circuit board (PCB), to change the equipment used to route the PCBs, and to add Kapton Tape to the battery surface to prevent contact with copper traces from the PCB and the adjacent surface of the battery.
P020014/S038
10/2/12
180-Day
Conceptus® Essure System for Permanent Birth Control Conceptus, Inc.
Mountain View, CA
94041
Approval for a material change and a minor process change. The use of new Carbothane materials in the delivery catheter with the new hydrophilic coating and a change in operating temperature.
P020018/S043
10/1/12
180-Day
The Zenith Fenestrated AAA Endovascular Graft Cook, Inc.
Bloomington, IN
47402
Approval of the post-approval study protocol.
P020018/S046
10/9/12
180-Day
Zenith® AAA Endovascular Graft System Cook Incorporated
Bloomington, IN
47402
Approval for modifications to the H & L-B One-Shot Introduction System.
P020056/S016
10/1/12
180-Day
Natrelle (formerly named) Silicone-filled Breast Implant Allergan
Santa Barbara, CA
93111
Approval of the post-approval study protocol.
P030017/S140
10/1/12
Real-Time
Precision Spinal Cord Stimulator (SCS) System Boston Scientific Neuromodulation
Valencia, CA
91355
Approval for minor packaging design changes to the inner tray and inner tray cover for the Precision Spinal Cord Stimulator (SCS) System Implantable Pulse Generator (IPG) kits.
P030029/S013
10/15/12
180-Day
ADVIA Centaur® Anti-HBs Assay Siemens Healthcare Diagnostics, Inc.
Walpole, MA
02032
Approval for a manufacturing site located at STRATEC Biomedical Switzerland AG in Beringen, Switzerland.
P030031/S045
10/2/12
Real-Time
ThermoCool SF Nav Uni-Directional Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for extending the Shelf Live for the catheter in the object of the current letter from one to three years.
P030040/S008
10/15/12
180-Day
ADVIA Centaur® HBc IgM Assay Siemens Healthcare Diagnostics, Inc.
Walpole, MA
02032
Approval for a manufacturing site located at STRATEC Biomedical Switzerland AG in Beringen, Switzerland.
P030049/S010
10/15/12
180-Day
ADVIA Centaur® HBsAg and HBsAg Confirmatory Assay Siemens Healthcare Diagnostics, Inc.
Walpole, MA
02032
Approval for a manufacturing site located at STRATEC Biomedical Switzerland AG in Beringen, Switzerland.
P030054/S232
10/16/12
Real-Time
Quartet IS4 Lead Models St. Jude Medical
Sylmar, CA
91342
Approval for changes to the packaging of the Quartet IS4 and Durata DF4 leads.
P030056/S007
10/15/12
180-Day
ADVIA Centaur® HCV Assay Siemens Healthcare Diagnostics, Inc.
Walpole, MA
02032
Approval for a manufacturing site located at STRATEC Biomedical Switzerland AG in Beringen, Switzerland.
P040004/S009
10/15/12
180-Day
ADVIA Centaur® HBc Total Assay Siemens Healthcare Diagnostics, Inc.
Walpole, MA
02032
Approval for a manufacturing site located at STRATEC Biomedical Switzerland AG in Beringen, Switzerland.
P040048/S017
10/25/12
135-Day
Trilogy AB Acetabular System Zimmer, Inc.
Warsaw, Indiana
46581
Approval for the addition of a new cleanroom.
P050023/S053
10/3/12
180-Day
Programmer Software PSW Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Evia HF/HF-T family of CRT-Ps and new programmer software identified as 1203.U/1.
P050033/S015
10/22/12
135-Day
Hydrelle, Dermal Filler Anika Therapeutics, Inc.
Bedford, MA
01730
Approval for a change in the sample preparation procedure for HPLC testing.
P050053/S022
10/17/12
135-Day
INFUSE Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for change in resin usage lifetime.
P050053/S026
10/25/12
135-Day
INFUSE® Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for the extension of the expiry of batch reference material.
P060002/S028
10/4/12
Special
Flair Endovascular Stent Graft C.R. Bard, Inc.
Tempe, AZ
85281
Approval for the incorporation of a new Leica DM2500M microscope and DFC295 digital camera to increase image resolution in order to measure material porosity in accordance with ISO 7198.
P060025/S009
10/26/12
180-Day
3f Aortic Bioprosthesis Medtronic ATS Medical, Inc.
Lake Forest, CA
92630
Approval of the post-approval study protocol.
P060037/S017
10/25/12
135-Day
Nexgen LPS/LPS Flex Mobile Knee Zimmer, Inc.
Warsaw, Indiana
46581
Approval for the addition of a new cleanroom.
P060038/S012
10/9/12
180-Day
Mitroflow Aortic Pericardial Heart Valve (MAPHV) Sorin Group USA, Inc.
Arvada, CO
80004
Approval for the Mitroflow Valsalva Conduit (MVC).
P060040/S024
10/5/12
Real-Time
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA
94588
Approval to extend the shelf-life of both the HeartMate II (HM II) Sealed Outflow Graft and the Sealed Inflow Conduit from the current labeling of three years to five years.
P070008/S031
10/3/12
180-Day
Evia HF/HF-T, Entovis HF/HF-T, Programmer Software PSW Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Evia HF/HF-T family of CRT-Ps and new programmer software identified as 1203.U/1.
P070015/S077
10/23/12
180-Day
XIENCE V® Everolimus Eluting Coronary Stent System and PROMUS® Everolimus Eluting Coronary Stent
System
Abbott Vascular
Temecula, CA
92589
Approval to use everolimus, the active pharmaceutical ingredient (API) in the devices, following a change in the manufacturing process implement by Novartis, the API manufacturer.
P080006/S006
10/4/12
180-Day
Attain Ability Left Ventricular Leads Medtronic, Inc.
Mounds View, MN
55113
Approval for component level analytical testing for release of the Model 4196, 4296 and 4396.
P080020/S002
10/10/12
135-Day
Gel-One® Seikagaku Corporation
Toyko, Japan
100-0005
Approval for the use of dedicated manufacturing equipment for additional purposes.
P090012/S002
10/2/12
180-Day
MelaFind Mela Sciences, Inc.
Irvington, NY
10533
Approval of the post-approval study protocol.
P090013/S073
10/4/12
180-Day
CapSureFix MRI SureScan Lead Medtronic, Inc.
Mounds View, MN
55112
Approval for a manufacturing site located at Medtronic Singapore Operation Pte, in Singapore.
P100005/S001
10/1/12
180-Day
M-Vu Algorithm Engine VuCOMP, Inc.
Plano, TX
75093
Approval for algorithm updates and the expansion to multiple mammography systems.
P100020/S002
10/18/12
135-Day
cobas® HPV Test Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a change in the DNA synthesizer instrument platform.
P100040/S008
10/26/12
Panel-Track
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 isolated lesions (excluding dissections) of the descending thoracic aorta in patients having appropriate anatomy, including: iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories; nonaneurysmal aortic diameter in the range of 18 to 42 mm (fusiform and saccular aneurysms/ penetrating ulcers) or 18 mm to 44 mm (blunt traumatic aortic injuries); and nonaneurysmal aortic proximal and distal neck lengths > 20 mm.
P110001/S009
10/9/12
180-Day
RX Herculink Elite Renal Stent System Abbott Vascular
Temecula, CA
92591
Approval for a manufacturing site located at Abbott Vascular Cardiac Therapies in Clonmel, Ireland.
P110019/S018
10/5/12
180-Day
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System Abbott Vascular, Inc.
Temecula, CA
92591
Approval to allow the corresponding drug content values to be centered around 100% label claim and provide increased probability that individual units will have a drug content of greater than 90% of the labeled claim to meet the condition of approval that "within 12 months of PMA approval, you should submit a PMA supplement requesting approval to tighten the in-process coating weight gain specification or implement procedures to re-coat stents with less than 95% coating weight gain upon in-process inspection. The company has provided the alternative solution.

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/S062
10/31/12
Anterior and Posterior Chamber Intraocular Lenses Alcon Laboratories, Inc.
Fort Worth, TX
76134
Change to add a new sterilization vendor.
P830061/S078
10/3/12
CapSure, Vitatron Crystalline, Vitatron Excellence PS+ Medtronic, Inc.
Mounds View, MN
55112
New annealing vacuum oven.
P830061/S079
10/25/12
CapSure. CapSure Sense, CapSure SP Novus, Vitatron Crystalline, and
Vitatron Excellence PS+ Leads
Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P830061/S080
10/26/12
Vitatron Excellence PS+ Medtronic, Inc.
Mounds View, MN
55112
New annealing vacuum oven.
P840001/S227
10/10/12
External Neurostimulator,
lntrel 4, Restore Prime, Prime Advanced, Restore,
Restore Ultra,
Restore Advanced and Restore Sensor
Medtronic Neuromodulation
Minneapolis, MN
55432
Use of the new Automated Assembly Equipment Controller software release, interfacing with the Manufacturing Execution System at the hybrid component supplier.
P840001/S228
10/24/12
Itrel 3, Synergy, Syngery Versitrel, Itrel 4, Pocket Adaptors, Soletra, Kinetra, Activa SC, InterStim, and Enterra Medtronic Neuromodulation
Minneapolis, MN
55432
Manufacture of one inner seal silicone component at the alternate supplier, Flexan located in Suzhou Industrial Park, China.
P840060/S038
10/31/12
Anterior and Posterior Chamber Intraocular Lenses Alcon Laboratories. Inc.
Fort Worth, TX
76134
Change to add a new sterilization vendor.
P850079/S057
10/17/12
Methafilcon A Soft Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Modify the inspection process.
P850089/S090
10/25/12
CapSure SP Novus, CapSure SP Z, CapSure Z Novus, and Vitatron
Impulse II Leads
Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P860057/S092
10/4/12
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis Edward Lifesciences
Irvine, CA
92614
Manufacturing software change to automate in-process labeling.
P870077/S047
10/4/12
Carpentier-Edwards S.A.V. Bioprosthesis Edward Lifesciences
Irvine, CA
92614
Manufacturing software change to automate in-process labeling.
P870056/S052
10/4/12
Carpentier-Edwards Porcine Bioprosthesis Edward Lifesciences
Irvine, CA
92614
Manufacturing software change to automate in-process labeling.
P880006/S083
10/10/12
Regency St. Jude Medical
Sylmar, CA
91342
Changes to the bioburden action level and bioburden action limit.
P880086/S226
10/10/12
Identity, Integrity, Affinity, Verity, Victory, Zephyr, Sustain, Accent St. Jude Medical
Sylmar, CA
91342
Changes to the bioburden action level and bioburden action limit.
P880086/S227
10/31/12
Identify, Verify, Victory, Zephyr, Accent Family of Pacemaker Devices St. Jude Medical, Inc.
Sylmar, CA
91342
Alternate supplier of the septum component.
P880087/S020
10/31/12
Anterior and Posterior Chamber Intraocular Lenses Alcon Laboratories, Inc.
Fort Worth, TX
76134
Change to add a new sterilization vendor.
P890003/S261
10/25/12
CapSure VDD-2 and Vitatron Brilliant S+ Leads Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P910023/S304
10/10/12
Current, Current Accel, Current+, Current RF, Fortify, Epic/Epic+,
Atlas/II/+
St. Jude Medical
Sylmar, CA
91342
Changes to the bioburden action level and bioburden action limit.
P910023/S306
10/31/12
Atlas/Atlas+, Atlas II/Atlas II+, Current, Current Accel, Current+, Epic/ Epic+, Epic II/Epic II+, Fortify, Fortify Assura, Ellipse Family of
ICD Devices
St. Jude Medical, Inc.
Sylmar, CA
91342
Alternate supplier of the septum component.
P910073/S106
10/3/12
Endotak Reliance EZ IS-1 and Endotak Reliance 4-Site Ez Quadripolar
(DF4) Active Fixation Leads Active Fixation Leads
Boston Scientific Corporation
St. Paul, MN
55112
Changes to the dexamethasone acetate drug substance specification and testing.
P910077/S124
10/24/12
Zoom LATITUDE Programming System Boston Scientific Corporation
St. Paul, MN
55112
Alternate component suppliers.
P910077/S125
10/24/12
LATITUDE RF Communicator Boston Scientific Corporation
St. Paul, MN
55112
Change to the main control board manufacturing line.
P920015/S095
10/3/12
Sprint Quattro, Sprint Quattro Lead Medtronic, Inc.
Mounds View, MN
55112
New annealing vacuum oven.
P920015/S096
10/15/12
“Y” adaptor/ extender kit, Spring Quattro Lead Medtronic, Inc.
Mounds View, MN
55112
Alternate suppliers for molded components.
P920015/S097
10/25/12
Sprint Quattro, Spring Quattro Secure, and Spring Quattro Secure S Leads Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P930014/S064
10/31/12
Anterior and Posterior Chamber Intraocular Lenses Alcon Laboratories, Inc.
Fort Worth, TX
76134
Change to add a new sterilization vendor.
P930031/S036
10/24/12
Wallstent Tips Endoprosthesis with Unistep Plus
Delivery System
Boston Scientific Corporation
Maple Grove, MN
55311
Change to the aeration cycle time for an ethylene oxide sterilization cycle.
P930031/S037
10/31/12
Wallstent Endo (TIPS) Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Alternate inspection equipment for the extruded tubing component.
P930039/S073
10/3/12
CapSureFix Novus Lead, Vitatron Crystalline Leads Medtronic, Inc.
Mounds View, MN
55112
New annealing vacuum oven.
P930039/S074
10/15/12
CapSureFix Novus Lead, Vitatron Crystalline Leads Medtronic, Inc.
Mounds View, MN
55112
Alternate suppliers for molded components.
P930039/S075
10/25/12
CapSureFix DXAC/DSP, CapSureFix Novus, SureFix, and Vitatron
Crystalline Lcuds
Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P940019/S031
10/24/12
Wallstent Iliac Endoprosthesis with Unistep Plus
Delivery System
Boston Scientific Corporation
Maple Grove, MN
55311
Change to the aeration cycle time for an ethylene oxide sterilization cycle.
P940019/S032
10/31/12
Wallstent Reduced Profile Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Alternate inspection equipment for the extruded tubing component.
P950005/S040
10/24/12
Celsius RF Ablation Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Addition of an alternate supplier for the extruding and braiding process.
P950020/S056
10/31/12
Flextome Cutting Balloon Boston Scientific Corporation
Maple Grove, MN
55311
A second proximal bond laser and several process changes to the Automatic Torch Box.
P950022/S084
10/10/12
Durata, Durata DF4 St. Jude Medical
Sylmar, CA
91342
Changes to the bioburden action level and bioburden action limit.
P950024/S043
10/3/12
CapSure Epicardial Pacing Lead Medtronic, Inc.
Mounds View, MN
55112
New annealing vacuum oven.
P950024/S045
10/25/12
CapSure Epicardial Pacing Lead Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P950037/S112
10/10/12
Philos DR/DR-B/ SR/SR-B/DR-T/II DR/II DR-T/II SR, Cylos DR/DR-T/VR,
Selox JT/ST, Setrox S, SLX BP, and Evia DR/DR-T/SR/SR-T
Biotronik, Inc.
Lake Oswego, OR
97035
Addition of suppliers for components used in the devices.
P960004/S055
10/3/12
Thinline II Sterox Leads Boston Scientific Corporation
St. Paul, MN
55112
Changes to the dexamethasone acetate drug substance specification and testing.
P960004/S056
10/10/12
Fineline II and Thinline II Leads Boston Scientific Corporation
St. Paul, MN
55112
Addition of an alternate supplier for the distal tip electrodes.
P960006/S035
10/3/12
Flextend Bipolar Pacing Leads Boston Scientific Corporation
St. Paul, MN
55112
Changes to the dexamethasone acetate drug substance specification and testing.
P960009/S157
10/10/12
External Neurostimulator, Activa PC, Activa SC and Activa RC Medtronic Neuromodulation
Minneapolis, MN
55432
Use of the new Automated Assembly Equipment Controller software release, interfacing with the Manufacturing Execution System at the hybrid component supplier.
P960009/S158
10/24/12
Itrel 3, Synergy, Syngery Versitrel, Itrel 4, Pocket Adaptors, Soletra, Kinetra, Activa SC, InterStim, and Enterra Medtronic Neuromodulation
Minneapolis, MN
55432
Manufacture of one inner seal silicone component at the alternate supplier, Flexan located in Suzhou Industrial Park, China.
P960013/S074
10/10/12
Tendril SDx, Tendril ST, Tendril STS, Optisense St. Jude Medical
Sylmar, CA
91342
Changes to the bioburden action level and bioburden action limit.
P960030/S037
10/10/12
Isoflex P, Isoflex Optim, Isoflex S St. Jude Medical
Sylmar, CA
91342
Changes to the bioburden action level and bioburden action limit.
P960040/S271
10/5/12
Punctua, Energen, Incepta, Teligen ICD Boston Scientific Corporation
St. Paul, MN
55112
Cleaning tool aid for the sealer heating plates.
P960040/S272
10/17/12
TELIGEN,
INCEPTA, ENERGEN, and PUNCTUA Implantable
Cardioverter High Energy Defibrillators
Boston Scientific Corporation
St. Paul, MN
55112
Changes to the final hybrid component electrical test and the addition of new test equipment.
P960040/S273
10/24/12
Punctua, Teligen, Energen and Incepta Implantable Cardioverter Defibrillators Boston Scientific Corporation
St. Paul, MN
55112
Move a component coating processes in-house.
P960040/S274
10/24/12
Cognis CRT-D Boston Scientific Corporation
St. Paul, MN
55112
Software updates for the E2 and FP (Final Pack) tests.
D970003/S139
10/5/12
Advantio, Ingenio Pacemaker Boston Scientific Corporation
St. Paul, MN
55112
Cleaning tool aid for the sealer heating plates.
P970003/S153
10/30/12
VNS Therapy System Cyberonics, Inc.
Houston, Texas
77058
Change and the use of alternate components on the printed circuit board for the Programming Wand.
P970004/S142
10/10/12
InterStim II Medtronic Neuromodulation
Minneapolis, MN
55432
Use of the new Automated Assembly Equipment Controller software release, interfacing with the Manufacturing Execution System at the hybrid component supplier.
P970004/S143
10/24/12
Itrel 3, Synergy, Syngery Versitrel, Itrel 4, Pocket Adaptors, Soletra, Kinetra, Activa SC, InterStim, and Enterra Medtronic Neuromodulation
Minneapolis, MN
55432
Manufacture of one inner seal silicone component at the alternate supplier, Flexan located in Suzhou Industrial Park, China.
P970013/S052
10/10/12
Microny St. Jude Medical
Sylmar, CA
91342
Changes to the bioburden action level and bioburden action limit.
D970012/S093
10/5/12
AMS 700 Inflatable Penile Prosthesis, AMS Ambicor Penile Prosthesis American Regulatory Systems, Inc.
Minneotonka, MN
55343
The silicon receiving inspection and milling processes to be streamlined and to remove duplicate testing to provide consistency for the entire silicone processes.
P970020/S075
10/23/12
Ultra and Zeta RX Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA
92591
Modification to the pyrogen sampling frequency.
P980016/S383
10/4/12
Maximo II, Protecta, Protecta XT, Secura, Virtuoso II DR/VR ICDs Medtronic, Inc.
Mounds View, MN
55112
Update to the Automatic Assembly Equipment Controller (AAEC) System.
P980023/S048
10/10/12
Kainox VCS, Linox S/T/SD/TD Biotronik, Inc.
Lake Oswego, OR
97035
Addition of suppliers for components used in the devices.
P980033/S025
10/24/12
Wallstent Venous Endoprosthesis with Unistep Plus
Delivery System
Boston Scientific Corporation
Maple Grove, MN
55311
Change to the aeration cycle time for an ethylene oxide sterilization cycle.
P980033/S026
10/31/12
Wallstent Endo (Venous) Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Alternate inspection equipment for the extruded tubing component.
P980035/S291
10/1/12
Advisa DR IPG Medtronic, Inc.
Mounds View, MN
55112
Change to the hybrid burn-in time.
P980035/S292
10/4/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa, Advisa DR and Relia IPGs Medtronic, Inc.
Mounds View, MN
55112
Update to the Automatic Assembly Equipment Controller (AAEC) System.
P980035/S293
10/15/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa IPG, Sigma DR IPG, Sigma S IPG Medtronic, Inc.
Mounds View, MN
55112
Alternate suppliers for molded components.
P980035/S295
10/31/12
Advisa DR IPG Medtronic, Inc.
Minneapolis, MN
55112
Elimination of the incoming inspection of a battery component at an internal supplier location.
P980050/S077
10/3/12
Transvene Lead Medtronic, Inc.
Mounds View, MN
55112
New annealing vacuum oven.
P980050/S078
10/25/12
Transvene CS/SVC Lead Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P990025/S034
10/24/12
Navi-Star RF Ablation Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Addition of an alternate supplier for the extruding and braiding process.
P000007/S034
10/4/12
Edwards Prima Plus Stentless Bioprosthesis Edward Lifesciences
Irvine, CA
92614
Manufacturing software change to automate in-process labeling.
P000012/S040
10/10/12
COBAS® AMPLICOR® Hepatitis C Virus Test and
COBAS® AmpliPrep/ COBAS® AMPLICOR® HCV Test
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Scale up of a bulk enzyme used in the manufacture of kit components.
P000025/S065
10/15/12
MED-EL COMBI 40+ Cochlear Implant System MED-EL Corporation
Durham, NC
27713
Addition of a new laser welding system for the purposes of welding implant housings to implant headers for the Mi1000 MED-EL CONCERT model cochlear implants.
P000040/S025
10/24/12
Genesys HTA System Boston Scientific Corporation
Marlborough, MA
01752
Supplier site change.
P000053/S045
10/5/12
AMS 800 Urinary Control System American Regulatory Systems, Inc.
Minnetonka, MN
55343
The silicon receiving inspection and milling processes to be streamlined and to remove duplicate testing to provide consistency for the entire silicone processes.
P010012/S302
10/3/12
Easytrak 2 LV -1 and IS-1, Easytrak 3 LV -1 and IS-1 and Acuity Spiral
Leads
Boston Scientific Corporation
St. Paul, MN
55112
Changes to the dexamethasone acetate drug substance specification and testing.
P010012/S303
10/6/12
Punctua, Energen, Incepta, Cognis CRT-D Boston Scientific Corporation
St. Paul, MN
55112
Cleaning tool aid for the sealer heating plates.
P010012/S304
10/17/12
COGNIS, INCEPT A, ENERGEN, and PUNCTUA Cardiac
Resynchronization High Energy Defibrillators
Boston Scientific Corporation
St. Paul, MN
55112
Changes to the final hybrid component electric test and the addition of new test equipment.
P010012/S305
10/24/12
Punctua, Cognis, Energen and Incepta Cardiac Resynchronization Therapy Defibrillators Boston Scientific Corporation
St. Paul, MN
55112
Move a component coating processes in-house.
P010012/S306
10/24/12
Teligen ICD Boston Scientific Corporation
St. Paul, MN
55112
Software updates for the E2 and FP (Final Pack) tests.
P010015/S176
10/3/12
Attain Bipolar OTW Lead Medtronic, Inc.
Mounds View, MN
55112
New annealing vacuum oven.
P010015/S177
10/1/12
Consulta and Syncra CRT-Ps Medtronic, Inc.
Mounds View, MN
55112
Change to the hybrid burn-in time.
P010015/S178
10/4/12
Consulta, Syncra CRT-Ps Medtronic, Inc.
Mounds View, MN
55112
Update to the Automatic Assembly Equipment Controller (AAEC) System.
P010015/S179
10/15/12
Attain Bipolar OTW Lead, Left Ventricular Pacing Lead Medtronic, Inc.
Mounds View, MN
55112
Alternate suppliers for molded components.
P010015/S180
10/25/12
Attain OTW Bipolar and Attain OTW Unipolar Lead Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P010015/S181
10/31/12
Consulta and Syncra CRT-Ps Medtronic, Inc.
Minneapolis, MN
55112
Elimination of the incoming inspection of a battery component at an internal supplier location.
P010019/S034
10/25/12
Lotrafilcon Contact Lenses for Extended Wear CIBA Vision Corporation
Duluth, GA
30097
Minor manufacturing change to the method for the monitoring and data
processing for all production modules of various lenses.
P010020/S026
10/5/12
AMS Acticon Neosphincter American Regulatory Systems, Inc.
Minnetonka, MN
55343
The silicon receiving inspection and milling processes to be streamlined and to remove duplicate testing to provide consistency for the entire silicone processes.
P010030/S036
10/18/12
LifeVest Wearable Cardioverter Defibrillator Zoll Lifecor Corporation
Pittsburg, PA
15238
Changes to the battery manufacturing process at the supplier location.
P010031/S335
10/4/12
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD, Maximo II CRT-D, Protecta CRT-D and Protecta XT CRT-D Medtronic, Inc.
Mounds View, MN
55112
Update to the Automatic Assembly Equipment Controller (AAEC) System.
P010041/S036
10/4/12
Carpentier-Edwards S.A.V. Bioprosthesis Edward Lifesciences
Irvine, CA
92614
Manufacturing software change to automate in-process labeling.
P010047/S023
10/23/12
ProGel™ Pleural Air Leak Sealant Neomend, Inc.
Irvine, CA
92618
Addition of a second supplier for the materials comprising the outer pouch, which maintains the sterile barrier and holds the applicator accessories.
P010068/S030
10/24/12
Celsius DS and Navi-Star DS RF Ablation Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Addition of an alternate supplier for the extruding and braiding process.
P020009/S094
10/31/12
Express 2 Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Alternate inspection equipment for the extruded tubing component.
P020022/S011
10/24/12
VERSANT® HCV RNA 3.0 Assay (bDNA) Siemens Healthcare Diagnostics, Inc.
E. Walpole, MA
02032
Change in microplate coating equipment for a component, and a change to add an incoming functional test for a supplier component.
P020047/S051
10/23/12
Vision and ML8 Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA
92591
Modification to the pyrogen sampling frequency.
P030005/S087
10/5/12
Invive CRT-P Boston Scientific Corporation
St. Paul, MN
55112
Cleaning tool aid for the sealer heating plates.
P030017/S143
10/11/12
Precision® Spinal Cord Stimulator System Boston Scientific Corporation
Valencia, CA
91355
Procurement of a fuse subassembly from a qualified supplier.
P030031/S048
10/24/12
Celsius Thermocool Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Addition of an alternate supplier for the extruding and braiding process.
P030035/S104
10/10/12
Anthem. Frontier II St. Jude Medical
Sylmar, CA
91342
Changes to the bioburden action level and bioburden action limit.
P030035/S105
10/31/12
Frontier, Frontier II, Anthem Family of CRT-P Devices St. Jude Medical, Inc.
Sylmar, CA
91342
Alternate supplier of the septum component.
P030036/S047
10/3/12
SelectSecure Lead Medtronic, Inc.
Mounds View, MN
55112
New annealing vacuum oven.
P030036/S048
10/15/12
Anchoring Sleeve Kit, SelectSecure Lead Medtronic, Inc.
Mounds View, MN
55112
Alternate suppliers for molded components.
P030036/S049
10/25/12
SelectSecure 4 French Lead Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P030054/S233
10/10/12
QuickFlex micro, Quartet, Promote, Promote+, Promote RF, Promote Accel, Promote Q, Promote Quadra, Unify, Unify Quadra, Epic, Atlas St. Jude Medical
Sylmar, CA
91342
Changes to the bioburden action level and bioburden action limit.
P030054/S235
10/31/12
Atlas+ HF/Atlas II HF, Atlas II+ HF, Epic+, Epic HF, Epic II HF, Epic II+ HF, Promote, Promote+, Promote RF, Promote Accel, Unify, Unify Quadra, Quadra Assura Family of CRT-D Devices St. Jude Medical, Inc.
Sylmar, CA
91342
Alternate supplier of the septum component.
P040016/S099
10/31/12
 
VeriFLEX (Libertè) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Alternate inspection equipment for the extruded tubing component.
P040020/S043
10/31/12`
Anterior and Posterior Chamber Intraocular Lenses Alcon Laboratories, Inc.
Fort Worth, TX
76134
Change to add a new sterilization vendor.
P040047/S024
10/18/12
Coaptite Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Addition of defect categories to an existing incoming inspection procedure.
P050012/S049
10/23/12
Dexcom SEVEN® PLUS Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA
92121
Change to a torque driver used in the receiver component assembly process of the device.
P050023/S055
10/10/12
Corox OTW UP Steriod, and Lumax 300 DR-T/340 DR-T/300 VR-T/340 VR-T/500 DT-T/540 DR -T/500 VR-T/540 VR-T/540 VRT-DX/300 HFT/340 HF-T/500 HF-T/540 HF-T Biotronik, Inc.
Lake Oswego, OR
97035
Addition of suppliers for components used in the devices.
P050028/S027
10/10/12
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Scale up of a bulk enzyme used in the manufacture of kit components.
P050037/S034
10/17/12
Radiesse Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Addition of defect categories to the incoming inspection procedures based on risk and commensurate with severity.
P050039/S012
10/17/12
Exactech Novation Ceramic Articulation Hip System Exactech, Inc.
Gainesville, FL
32653
Addition of a new sealer.
P050044/S024
10/4/12
Vitagel Surgical Hemostat Stryker Orthobiologics
Malvern, PA
19355
Relocate certain Vitagel Surgical Hemostat assembly and packaging manufacturing equipment within the current manufacturing facility.
P050046/S016
10/3/12
Acuity Steerable Leads Boston Scientific Corporation
St. Paul, MN
55112
Changes to the dexamethasone acetate drug substance specification and testing.
P050047/S028
10/25/12
JUVÉDERM Hyaluronate Gel Implants Allergan Change in the residual crosslinker analysis method for the device.
P050052/S037
10/17/12
Radiesse Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Addition of defect categories to the incoming inspection procedures based on risk and commensurate with severity.
P060006/S035
10/31/12
Express SD Renal Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Alternate inspection equipment for the extruded tubing component.
P060007/S021
10/15/12
ARCHITECT HBsAg and HBsAg Confirmatory Abbott Laboratories
Abbott Park, IL
60064
Change in test method used for the determination of antibody activity during manufacture.
P060008/S098
10/31/12
TAXUS Liberté Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Alternate inspection equipment for the extruded tubing component.
P060022/S014
10/4/12
Akreos Intraocular Lenses Bausch & Lomb, Inc.
Aliso Viejo, CA
92656
New supplier for the 2-hydroxyl ethyl methacrylate (HEMA) monomer used in the manufacture of Akreos IOLs.
P060030/S029
10/10/12
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test For Use With The High Pure System Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Scale up of a bulk enzyme used in the manufacture of kit components.
P060039/S036
10/3/12
Attain StarFix Lead Medtronic, Inc.
Mounds View, MN
55112
New annealing vacuum oven.
P060039/S037
10/15/12
Attain StarFix Lead Medtronic, Inc.
Mounds View, MN
55112
Alternate suppliers for molded components.
P060039/S038
10/25/12
Attain StarFix Lead Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P070008/S034
10/10/12
Corox OTW-S BP/OTW-L BP Biotronik, Inc.
Lake Oswego, OR
97035
Addition of suppliers for components used in the devices.
P070015/S101
10/23/12
XIENCE V and XIENCE nano Everolimus-Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA
92591
Modification the pyrogen sampling frequency.
P080006/S044
10/3/12
Attain Ability Leads Medtronic, Inc.
Mounds View, MN
55112
New annealing vacuum oven.
P080006/S045
10/25/12
Attain Ability Leads Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P080025/S038
10/10/12
InterStim II Medtronic Neuromodulation
Minneapolis, MN
55432
Use of the new Automated Assembly Equipment Controller software release, interfacing with the Manufacturing Execution System at the hybrid component supplier.
P080025/S039
10/24/12
Itrel 3, Synergy, Syngery Versitrel, Itrel 4, Pocket Adaptors, Soletra, Kinetra, Activa SC, InterStim, and Enterra Medtronic Neuromodulation
Minneapolis, MN
55432
Manufacture of one inner seal silicone component at the alternate supplier, Flexan located in Suzhou Industrial Park, China.
P090003/S016
10/12/12
Express LD Illiac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Addition of an alternate electropolishing recipe.
P090003/S017
10/23/12
Express LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Use of a new extrusion die.
P090007/S010
10/4/12
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV for use on the
cobas e 411 Immunoassay Analyzer
Roche Diagnostics Corporation
Indianapolis, IN
46250
Harmonization of the lyophilization process for peptide manufacturing.
P090008/S011
10/4/12
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV for use on the cobas e 601 Immunoassay Analyzer Roche Diagnostics Corporation
Indianapolis, IN
46250
Harmonization of the lyophilization process for peptide manufacturing.
P090009/S010
10/4/10
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV for use on the MODULAR ANALYTICS E170 Analyzer Roche Diagnostics Corporation
Indianapolis, IN
46250
Harmonization of the lyophilization process for peptide manufacturing.
P090013/S074
10/15/12
CapSureFix MRI Lead Medtronic, Inc.
Mounds View, MN
55112
Alternate suppliers for molded components.
P090013/S075
10/25/12
CapSureFix MRI Lead Medtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection location for various components.
P090013/S076
10/31/12
Revo MRI IPG Medtronic, Inc.
Minneapolis, MN
55112
Elimination of the incoming inspection of a battery component at an internal supplier location.
P090028/S003
10/17/12
VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Change to the manufacturing process and storage conditions of the antifoam solution.
P100001/S002
10/17/12
VITROS® Immunodiagnostic Products Anti-HBc Reagent Pack, Calibrator and Controls Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Change to the manufacturing process and storage conditions of the antifoam solution.
P100010/S019
10/10/12
Arctic Front Cardiac and Arctic Front Advance CryoAblation Catheters Medtronic, Inc.
Mounds View, MN
55112
Change in the outer balloon curing fixture and process changes.
P100013/S006
10/12/12
EXOSEAL Vascular Closure Device Cordis Corporation
Bridgewater, NJ
08807
An alternate tool for positioning a component and the addition of two optical sensors.
P100023/S055
10/24/12
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Changes to weld and heat shrink removal process parameters.
P110007/S001
10/9/12
Abbott Medical Optics (AMO) Heaton EndoCoat Ophthalmic Viscosurgical Device (3% Sodium Hyaluronate Ophthalmic Viscosurgical Device) Abbott Medical Optics, Incorporated
Santa Ana, CA
92705
Change from a manual to an automated process for the syringe and carton assemblies.
P110010/S030
10/24/12
PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Changes to weld and heat shrink removal process parameters.
P110019/S033
10/11/12
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems Abbott Vascular
Temecula, CA
92591
Add an alternate compressed gas in the manufacturing of the devices.
P110019/S034
10/23/12
XIENCE Prime and XIENCE Prime LL Everolimus-Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA
92591
Modification to the pyrogen sampling frequency.
P110029/S005
10/15/12
ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory Abbott Laboratories
Abbott Park, IL
60064
Change in test method used for the determination of antibody activity during manufacture.

Summary of PMA Originals & Supplements Approved
Originals: 7
Supplements: 69

Summary of PMA Originals Under Review
Total Under Review: 51
Total Active: 21
Total On Hold: 30

Summary of PMA Supplements Under Review
Total Under Review: 555
Total Active: 392
Total On Hold: 163

Summary of All PMA Submissions Received
Originals: 2
Supplements: 71

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 69
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 164
FDA Time: 123.6 Days MFR Time: 40.4 Days

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