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U.S. Department of Health and Human Services

Medical Devices

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January 2012 PMA Approvals

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
P100005
1/23/12
M-Vu Algorithm Engine VuCOMP, Inc.
Plano, TX
75093
Approval for the M-Vu Algorithm Engine. The device is indicated for use in screening mammography to identify areas consistent with breast cancer for radiologist review after completing an initial read.
P100039
1/20/12
ADVIA Centaur Anti-HBs2 (aHBs2) Assay and
ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA Centaur and ADVIA Centaur XP Systems
Siemens Healthcare Diagnostics
Tarrytown, NY
10591
Approval for ADVIA Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA Centaur and ADVIA Centaur XP Systems. The device is indicated for: ADVIA Centaur Anti-HBs2 (aHBs2) Assay – The ADVIA Centaur anti-HB2 assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis B surface antigen in human adult, adolescent, and pediatric serum of plasma (EDTA, lithium-heparinized, or sodium-heparinized) and neonatal samples using the ADVIA Centaur and ADVIA Centaur XP Systems. The assay results may be used as an aid in the determination of susceptibility to 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.
This assay has not been FDA-cleared or approved for the screening of blood or plasma donors. ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material – For in vitro diagnostic use in monitoring the performance of the Anti-HBs2 assay on the ADVIA Centaur Systems. The performance of the Anti-HBs2 quality control material has not been established with any other anti-HBs assays.
P110016
1/25/12
Therapy Cool Path Duo™ Ablation Catheter; Safire BLU Duo™ Ablation Catheter; and IBI 1500T9-CP V1.6 Cardiac Ablation Generator Irvine Biomedical, Inc.
Irvine, CA
92614
Approval for the Therapy Cool Path Duo™ Ablation Catheter; Safire BLU Duo™ Ablation Catheter; and IBI 1500T-9 VI.6 Cardiac Ablation Generator. The device is indicated for use with the compatible Irrigation pump and 1500T9-CP Radiofrequency (RF) Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
P110031
1/3/12
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer Roche Diagnostics
Indianapols, IN
46250
Approval for the Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer. The device is indicated for: Elecsys® Anti-HBc IgM Immunoassay – The Elecsys® Anti-HBc IgM Immunoassay is intended for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) in adult patients with symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis B virus (HBV) infection. The Elecsys® Anti-HBc IgM Immunoassay’s performance has not been established for the monitoring of HBV disease or therapy.
The electrochemi- luminescence immunoassay “ECLIA” is intended for use on the cobas e 411 immunoassay analyzer.
Elecsys® PreciControl Anti-HBc IgM - The Elecsys® PreciControl Anti-HBc IgM is used for the quality control of the Elecsys® Anti-HBc IgM Immunoassay on the cobas e 411 immunoassay analyzer.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N16837/S008
1/10/12
135-Day
Artegraft Collagen Vascular Graft Artegraft, Inc.
North Brunswick, NJ
08902
Approval for the addition of an alternative supplier of a major component for the manufacturing of the device.
N17600/S026
1/23/12
Special
Avitene Microfibrillar Collagen Hemostat/ Flour and Avitene Microfibrillar Collagen Hemostat/ Non-Woven Web Davol, Incorporated
Warwick, RI
02886
Approval for the addition of a precautions section to the Instructions for Use for the Avitene family of products. The additional language is as follows: "Any excess Avitene MCH not removed at the time of surgery may either present itself as a
(recurring) mass or a (space occupying) lesion or it may lead to a foreign body reaction that may present with or without clinical signs and symptoms as a recurring mass or lesion or postoperative abscess formation upon imaging. Imaging may initially not be capable of distinguishing the difference. Removal of excess material, ideally performed upon conclusion of the initial procedure, typically resolves all signs and symptoms."
P800002/S018
1/23/12
180-Day
Avitene Microfibrillar Collagen Hemostat/ Flour and Avitene Microfibrillar Collagen Hemostat/ Non-Woven Web Davol, Incorporated
Warwick, RI
02886
Approval for the addition of a precautions section to the Instructions for Use for the Avitene family of products. The additional language is as follows: "Any excess Avitene MCH not removed at the time of surgery may either present itself as a
(recurring) mass or a (space occupying) lesion or it may lead to a foreign body reaction that may
present with or without clinical signs and symptoms as a recurring mass or lesion or
postoperative abscess formation upon imaging. Imaging may initially not be capable of
distinguishing the difference. Removal of excess material, ideally performed upon conclusion of
the initial procedure, typically resolves all signs and symptoms."
P810025/S029
1/17/12
180-Day
Amvisc and Amvisc Plus Anika Therapeutics, Incorporated
Bedford, MA
01730
Approval for a manufacturing site located at Anika Therapeutics, Inc., in Bedford, Massachusetts.
P830055/S119
1/6/12
135-Day
LCS Total Knee System DePuy Orthopedics, Inc.
Warsaw, IN
46581
Approval for changes to the final cleaning and passivation processes for the femoral device.
P860004/S147
1/20/12
180-Day
Medtronic Catheters Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Co., in Juncos, Puerto Rico.
P860004/S151
1/13/12
135-Day
SynchroMed II Infusion Pump Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for a manufacturing change related to the desiccant inspection step for the SynchroMed II Infusion Pump, Model 8637.
P890003/S179
1/9/12
180-Day
Medtronic® CareLink Monitor, CardioSight® Reader and DDMA Medtronic, Inc.
Mounds View, MN
55112
Approval for the DF4 Connector System, which is comprised of the ICD, CRT-D and defibrillation lead devices for the devices.
P890055/S035
1/5/12
135-Day
MedStream Programmable Infusion System Codman & Shurtleff, Inc.
Raynham, MA
02767
Approval for an alternate supplier for the passivation of components needed to manufacture accessories used with the Codman 3000 Series Constant Flow Implantable Infusion Pump and MedStream Programmable Infusion Pump.
P890057/S020
1/31/12
135-Day
High Frequency Oscillating Ventilator CareFusion
Yorba Linda, CA
92887
Approval for the addition of an adhesive to the welded joints of the breathing circuit hub in the device.
P910001/S047
1/13/12
180-Day
ECLA Coronary Atherectomy Catheters Spectranetics Corporation
Colorado Springs, CO
80906
Approval for a manufacturing site located in Colorado Springs, Colorado.
P910071/S013
1/24/12
Real-Time
ADATO® SIL-OL 5000 Silicone Oil Bausch & Lomb, Inc.
Aliso Viejo, CA
92656
Approval for the addition of a heat shrink tube to the primary packaging for the device to assure a tighter fit between the luer adapter and the syringe barrel body.
P910073/S091
1/5/12
180-Day
ENDOTAK RELIANCE IS-1 Passive Fixation Leads Boston Scientific CRV
St. Paul, MN
55112
Approval for drug material and supplier changes as well as distal tip design changes.
P920015/S055
1/9/12
180-Day
Medtronic® Sprint Quattro Secure® Defibrillation Lead Medtronic, Inc.
Mounds View, MN
55112
Approval for the DF4 Connector System, which is comprised of the ICD, CRT-D and defibrillation lead devices for the devices.
P940016/S014
1/13/12
180-Day
H.E.L.P. Plasmat® Futura Apheresis System B. Braun Medical, Inc.
Allentown, PA
18109
Approval for a change in the potting resin used to anchor the membranes of the Heparin Adsorber and the Plasmafilter Haemoselect components of the system.
P940035/S007
1/20/12
180-Day
Alere™ NMP22® Test Kit, Alere™ NMP22®Urine Collection Kit Alere Scarborough, Inc.
Scarborough, ME
04074
Approval for the NMP22® Test Kit and NMP22 Urine Collection Kit under Alere Scarborough, Inc.’s brand name. The devices, as modified, will be marketed under: Trade name Alere™ NMP22® Test with the following Intended Use: Alere™ NMP22® Test is an enzyme immunoassay (EIA) for the in vitro quantitative determination of the nuclear mitotic apparatus protein (NuMA) in stabilized voided urine. The Alere™ NMP22® Test Kit is indicated as an aid 1) in the diagnosis of persons with symptoms or risk factors for transitional cell cancer (TCC) of the bladder (cut-off ≥ 7.5 U/mL) in conjunction with, and not in lieu of, current standard diagnostic procedures, and 2) in management of patients of transitional cell carcinoma of the bladder, after surgical treatment to identify those patients with occult or rapidly recurring TCC (cut-off > 10 U/mL).
Trade name Alere™ NMP22® Urine Collection Kit, with the following Intended Use: The Alere™ NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will be tested using the Alere™ NMP22® Test Kit.
P960042/S029
1/13/12
180-Day
Spectranetics Laser Sheath (SLS) Spectranetics Corporation
Colorado Springs, CO
80906
Approval for a manufacturing site located in Colorado Springs, Colorado.
P970020/S065
1/6/12
135-Day
MultiLink Zeta, Pixel and ULTRA Coronary Stent Systems Abbott Vascular
Temecula, CA
92590
Approval for a new automated tubing extrusion measurement process.
P980016/S216
1/9/12
180-Day
Medtronic® Secura® DR D204DRM and Maximo® II D264DRM Implantable Cardioverter Defibrillators, Model 9995 v7.3 application software Medtronic, Inc.
Mounds View, MN
55112
Approval for the DF4 Connector System, which is comprised of the ICD, CRT-D and defibrillation lead devices for the devices.
P000010/S024
1/11/12
180-Day
AMPLICOR HCV Test, v2.0 Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a change to the test method for determination of Dithiothreitol in bulk and vialed lysis reagents.
P000012/S033
1/11/12
180-Day
COBAS AMPLICOR HCV Test, v2.0 and COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, v2.0 Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a change to the test method for determination of Dithiothreitol in bulk and vialed lysis reagents.
P000013/S010
1/18/12
Real-Time
Osteonics ABC/Trident Systems Howmedica Osteonics Corporation
Mahwah, NJ
07430
Approval for the addition of the Tritanium PSF Acetabular Shells (solid-backed and cluster screw-hole designs) as compatible components with the Trident Ceramic Inserts, as well as modifications to the tolerances and surface roughness values of the taper region of all compatible Trident and Tritanium Acetabular Shells. In addition, labeling changes were made to address the compatibility with the new components.
P000023/S006
1/31/12
180-Day
TMJ Fossa-Eminence and Condylar Prosthesis System TMJ Medical
Golden, CO
80401
Approval for labeling changes to update the owner and company name, manufacturing suite, standardization of the product names, and adverse events section related to completion of the post-approval study.
P000035/S006
1/31/12
180-Day
TMJ Fossa-Eminence Prosthesis System TMJ Medical
Golden, CO
80401
Approval for labeling changes to update the owner and company name, manufacturing suite, standardization of the product names, and adverse events section related to completion of the post-approval study.
P000039/S043
1/10/12
Special
AMPLATZER® Septal Occluder AGA Medical Corporation
Plymouth, MN
55442
Approval for labeling changes regarding device erosion.
P000040/S020
1/24/12
180-Day
Genesys HTA™ System Boston Scientific Corporation
Marlborough, MA
01752
Approval for software changes to the Genesys HTA System control Unit.
P000046/S017
1/17/12
180-Day
Staarvisc II and Shellgell Anika Therapeutics, Incorporated
Bedford, MA
01730
Approval for a manufacturing site located at Anika Therapeutics, Inc., in Bedford, Massachusetts.
P010031/S176
1/9/12
180-Day
Medtronic® Consulta® CRT-D D204TRM and Maximo® II CRT-D D264TRM Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Model 9995 v7.3 application software Medtronic, Inc.
Mounds View, MN
55112
Approval for the DF4 Connector System, which is comprised of the ICD, CRT-D and defibrillation lead devices for the devices.
P020002/S006
1/23/12
Real-Time
Review Scope Manual+ Hologic, Inc.
Marlborough, MA
01752
Approval for the Review Scope Manual+.
P020026/S082
1/27/12
180-Day
CYPHER® Sirolimus-Eluting Coronary Stent on SONIX™ Rapid Exchange Delivery System Cordis Corporation
Miami Lakes, FL
33014
Approval for the SONIX™ Rapid Exchange Delivery System for the CYPHER Sirolimus-eluting Coronary Stent.
P020026/S085
1/26/12
180-Day
CYPHER® Sirolimus-Eluting Coronary Stent on SONIX™ RX Delivery System Cordis Corporation
Miami Lakes, FL
33014
Approval to integrate the XTEND manufacturing process into the CYPHER Stent mounted on the SONIX RX delivery system.
P020047/S036
1/6/12
135-Day
Vision, MiniVision and ML8 Coronary Stent Systems Abbott Vascular
Temecula, CA
92590
Approval for a new automated tubing extrusion measurement process.
P030031/S033
1/13/12
135-Day
NAVISTAR RMT ThermoCool Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a second source supplier of a catheter component.
P040012/S039
1/6/12
135-Day
Acculink Cartoid Stent System Abbott Vascular
Temecula, CA
92590
Approval for a new automated tubing extrusion measurement process.
P040024/S053
1/26/12
180-Day
Restylane Injectable Gel Medicis Pharmaceutical Corporation
Scottsdale, AZ
85256
Approval for a relocation of the current Quality Control laboratory (QC-lab) for chemical, microbiological and receiving inspection analysis to a new location with Q-Med’s existing facilities.
P040036/S024
1/13/12
135-Day
NAVISTAR RMT ThermoCool Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a second source supplier of a catheter component.
P040043/S040
1/13/12
180-Day
GORE TAG Thoracic Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval for the GORE TAG Thoracic Endoprosthesis. The device is intended for endovascular repair of isolated lesions (not including dissections) of the descending thoracic aorta, in patients who have appropriate anatomy including adequate iliac/femoral access, aortic inner diameter in the range of 16-42 mm, and ≥ 20 mm non-aneurysmal aorta proximal and distal to the lesion.
P040044/S040
1/13/12
Real-Time
MynxGrip™ Vascular Closure Device Access Closure
Mountain View, CA
94043
Approval for integrating the catheter delivery system of the Mynx
Cadence device with the hydrogel sealant of the Mynx with Grip Technology device. The device,
as modified, will be marketed under the trade name MynxGrip ™ 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 6F or 7F procedural sheath.
P050019/S008
1/27/12
180-Day
Carotid WALLSTENT Monorail Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311
Approval for modifications to the labeling to include the post-approval study findings.
P050044/S019
1/31/12
180-Day
Vitagel™ Surgical Hemostat Stryker Corporation
Malvern, PA
19355
Approval for a design change (removal of the metering knob) to the CellPaker component of the Vitagel Surgical Hemostat system, introduction of a new contract manufacturer located at Tegra Medical in Darthmouth, Massachusetts, a change to the packaging materials and sterilization methods for the system component, and the re-branding of the CellPaker component as VitaPrep Plasma Separator.
P050047/S018
1/20/12
135-Day
Juvederm Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Approval to add additional testing on two raw materials used in the manufacture of the device which included additional testing of raw materials.
P050047/S020
1/20/12
Real-Time
Juvederm Ultra XC and Juvederm Ultra Plus XC
 
 
Allergan
Goleta, CA
93117
Approval for an extension of the shelf life from 12 months to 18 months for the 1.0mL syringe; an increase in the monoethylglycin-exylidide (MEGX) impurity specification from ≤0.3% w/w of label strength to ≤2.5% w/w of label strength; and an increase in individual unidentified impurities specifications from
≤0.1% w/w of label strength to ≤0.2% w/w of label strength.
P070006/S006
1/4/12
180-Day
T-SPOT.TB Test Oxford Immunotec, Ltd.
Toms River, NJ
08754
Approval for the use of T-Cell Xtend reagent in extending whole blood storage from 0-32 hours prior to assaying with the T-SPOT.TB test.
P070015/S075
1/6/12
135-Day
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent Systems (EECSS) Abbott Vascular
Temecula, CA
92590
Approval for a new automated tubing extrusion measurement process.
P100021/S012
1/6/12
180-Day
Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Approval of the post-approval study protocol.
P100034/S001
1/3/12
180-Day
NovoTTF-100A Treatment Kit NovoCure, Ltd.
Rye Beach, NH
03871
Approval of the post-approval study protocol.
P100041/S001
1/31/12
180-Day
Edwards Sapien Transcatheter Heart Valve Edwards Life Sciences
Irvine, CA
92614
Approval of the post-approval study protocol.
P110019/S002
1/4/12
Real-Time
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92590
Approval to update the labeling for the XIENCE PRIME Everolimus Eluting Coronary Stent System to reflect an 180 month shelf life.

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
P790005/S048
1/20/12
EBI Osteogen Implantable Bone Growth Stimulator Biomet Spine & Bone Healing Technologies d.b.a. EBI, LLC
Parsippany, NJ
07054
Addition of new in-process package seal strength tests.
P840001/S201
1/12/12
RestoreSensor Implantable Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Three software changes, automation of the Bond Pad Array manufacturing process, and minor changes to the ethylene oxide residual testing procedures.
P840001/S202
1/13/12
Spinal Cord Stimulation (SCS) Leads Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of two new desktop welding stations with updated power supplies, and two process changes to include the consolidation of production laser weld program code and reducing frequency parameters for the welding process.
P840001/S203
1/20/12
Itrel 3 Implantable Neurostimulator, Synergy Family of Implantable Neurostimulators and Restore Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Thermal processing of Eccobond epoxy resin E3450(A) prior to consumption in routine manufacturing.
P840064/S047
1/20/12
PROVISC, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Devices Alcon Laboratories, Inc.
Fort Worth, TX
76134
Changes to the syringe component sterilization processes.
P860003/S063
1/10/12
THERAKOS CELLEX Photopheresis Procedure Kit THERAKOS, Inc.
Raritan, NJ
08869
Change in the tube cutting process.
P860057/S082
1/19/12
Carpentier-Edwards PERIMOUNT Pericardial Bioprostheses Edwards Lifesciences, Inc.
Irvine, CA
92614
Addition of Hawkins Inc., as an alternate supplier of sodium chloride.
P860057/S083
1/18/12
Carpentier-Edwards PERIMOUNT Bioprosthetic Valve Edwards Lifesciences, Inc.
Irvine, CA
92614
Additional supplier of bovine tissue.
P870056/S045
1/19/12
Carpentier-Edwards Bioprostheses and Valved Conduit Edwards Lifesciences, Inc.
Irvine, CA
92614
Addition of Hawkins Inc., as an alternate supplier of sodium chloride.
P870077/S041
1/19/12
Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis Edwards Lifesciences, Inc.
Irvine, CA
92614
Addition of Hawkins Inc., as an alternate supplier of sodium chloride.
P890003/S243
1/18/12
Prodigy IPGs Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing component used during routine manufacturing.
P890047/S035
1/20/12
PROVISC, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Devices Alcon Laboratories, Inc.
Fort Worth, TX
76134
Changes to the syringe component sterilization processes.
P890055/S038
1/17/12
Codman 3000 Series Constant Flow Implantable Infusion Pump and Accessories Codman & Shurtleff, Inc.
Raynham, MA
02767
Manufacturing process change to the device used with the Codman 3000 Series Constant Flow Implantable Infusion Pump and MedStream Programmable Infusion Pump.
P900066/S011
1/5/12
ISPAN Perfluoropropane C3F8 Gas Air Liquide Healthcare America Corporation
Plumsteadville, PA
18949
Replacement of the ion chromatograph.
P900067/S007
1/20/12
IPSAN Sulfur Hexafluoride SF6 Gas Air Liquide Healthcare America Corporation
Plumsteadville, PA
18949
Replace the ion chromatograph for Quality Control product testing.
P940015/S024
1/5/12
Synvisc® and Synvisc-One® Genzyme Corporation
Cambridge, MA
02142
Addition of a larger filling vessel.
P960009/S135
1/13/12
Deep Brain Stimulation (DBS)
Leads
Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of two new desktop welding stations with updated power supplies, and two process changes to include the consolidation of production laser weld program code and reducing frequency parameters for the welding process.
P960009/S136
1/20/12
Soletra Neurostimulator, Kinetra Neurostimulator and Activa Family of Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Thermal processing of Eccobond epoxy resin E3450(A) prior to consumption in routine manufacturing.
P960011/S020
1/27/12
BVI 1% OVD (1% Sodium Hyaluronate Viscoelastic Surgical Aid Fluid) Ferring Pharmaceuticals Incorporated
Parsippany, NJ
07054
New viscometer for the in-process and Quality Control release testing.
P960040/S247
1/13/12
Teligen, Incepta, Energen, Punctua ICDs Boston Scientific Corporation
St. Paul, MN
55112
Use of a new cathode material in the high voltage capacitor and a new supplier.
P960040/S248
1/19/12
Teligen, Incepta, Energen, Punctua CRT-Ds Boston Scientific CRM
St. Paul, MN
55112
Addition of a new supplier for a resistor component.
P960040/S249
1/25/12
Teligen, Incepta, Energen, Punctua ICDs Boston Scientific Corporation
St. Paul, MN
55112
Manufacture of the battery component to be manufactured internally at its Boston Scientific
St. Paul manufacturing facility.
P960040/S250
1/26/12
TELIGEN, INCEPTA, ENERGEN, PUNCTUA and CONFIENT Implantable Cardioverter Defibrillators Boston Scientific Corporation
St. Paul, MN
55112
Addition of a new supplier for the antenna sock component, and for changes to the receiving acceptance activities.
P970003/S143
1/18/12
VNS Therapy System Cyberonics, Inc.
Houston, TX
77058
Changes to the parallel gap welding step during the manufacturing of the leads for the device.
P970004/S127
1/13/12
InterStim Leads Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of two new desktop welding stations with updated power supplies, and two process changes to include the consolidation of production laser weld program code and reducing frequency parameters for the welding process.
P970004/S128
1/20/12
InterStim Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Thermal processing of Eccobond epoxy resin E3450(A) prior to consumption in routine manufacturing.
P970012/S129
1/31/12
Interstim Sacral Nerve Stimulation Therapy System, Test Stimulation Lead and Stimulation Lead Kit Medtronic Neuromodulation
Minneapolis, MN
55432
Alternate supplier for a process for coating conductor wire.
P970012/S090
1/18/12
Kappa 400 DR/SR IPGs Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing component used during routine manufacturing.
P980016/S333
1/18/12
Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II, Virtuoso II, Secura, Protecta XT, Protecta, and ProtectaXT/Protecta DF4 ICDs Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing component used during routine manufacturing.
P980035/S255
1/18/12
Kappa 700/800/900, Sigma, Medtronic 350, EnPulse, EnRhythm, AT500, Adapta/Versa/
Sensia, Relia and Advisa DR IPGs
Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing component used during routine manufacturing.
P980049/S068
1/11/12
Paradym VR and Paradym DR ICDs Sorin CRM USA, Inc.
Plymouth, MN
55441
In-sourcing of an electronic assembly.
P990001/S099
1/18/12
Dema, C-Series and T-Series IPGs Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing component used during routine manufacturing.
P000007/S028
1/19/12
Edwards Prima Plus Stentless Biprosthesis Edwards Lifesciences, Inc.
Irvine, CA
92614
Addition of Hawkins Inc., as an alternate supplier of sodium chloride.
P010012/S275
1/13/12
Cognis, Incepta, Energen, Punctua CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Use of a new cathode material in the high voltage capacitor and a new supplier.
P010012/S276
1/19/12
Cognis, Incepta, Energen, Punctua CRT-Ds Boston Scientific CRM
St. Paul, MN
55112
Addition of a new supplier for a resistor component.
P010012/S277
1/25/12
Cognis, Incepta, Energen, Punctua CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Manufacture of the battery component to be manufactured internally at its Boston Scientific
St. Paul manufacturing facility.
P010012/S278
1/26/12
COGNIS, INCEPTA, ENGERGEN, PUNCTUA, LIVIAN Cardiac Resynchronization Therapy-Defibrillators Boston Scientific Corporation
St. Paul, MN
55112
Addition of a new supplier for the antenna sock component, and for changes to the receiving acceptance activities.
P010015/S151
1/18/12
InSync, InSync III, Consulta and Syncra CRT-Ps Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing component used during routine manufacturing.
P010019/S027
1/10/12
Lotrafilcon B Soft Contact Lenses for Extended Wear CIBA VISION Corporation
Duluth, GA
30097
Automation of the Tray Transfer System.
P010029/S013
1/27/12
EUFLEXXA
(1% Sodium Hyaluronate)
Ferring Pharmaceuticals Incorporated
Parsippany, NJ
07054
New viscometer for the in-process and Quality Control release testing.
P010031/S286
1/18/12
InSync Marquis, InSync II Marquis, InSync III Marquis, InSync Sentry, and Insync Maximo ICDs and Concerto, Concerto II, Maximo II, Consulta, Protecta XT, Protecta and Protecta DF4
CRT-Ds
Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing component used during routine manufacturing.
P010032/S044
1/6/12
The EonMini IPG St. Jude Medical
Plano, TX
75024
Add a backside lamination to components installed on the printed circuit board (PCB).
P010032/S045
1/19/12
Genesis, Eon, EonC Eon Mini Neurostimulation Systems St. Jude Medical
Piano, TX
75024
Manufacturing process change to add an in-process inspection step for the devices.
P010041/S029
1/19/12
Carpentier-Edwards Supraannular (S.A.V.) Bioprosthesis Edward Lifesciences, Inc.
Irvine, CA
92614
Addition of Hawkins Inc., as an alternate supplier of sodium chloride.
P020004/S068
1/13/12
EXCLUDER AAA Endo Catheter W.L. Gore & Associates, Inc.
Flagstaff, AZ
86003
Use of additional manufacturing equipment for laser cutting.
P020045/S041
1/13/12
Freezor® Cardiac CryoAblation Catheter, Freezor® Xtra Surgical Cardiac CryoAblation Device and Freezor® MAX Surgical Cardiac CryoAblation Device Medtronic CryoCath, LP
Pointe Claire, Quebec, Canada
H9R 5Z8
Streamlining the inspection procedure for the Freezor® family of catheters.
P030017/S125
1/4/12
Precision Spinal Cord Stimulator (SCS) System Boston Scientific Neuromodulation
Valencia, CA
91355
A new fabrication site for the supplier of the Analog Integrated Circuit (IC) in the Printed Circuit Board Assembly (PCBA) of the Implantable Pulse Generator (IPG) for the Precision Spinal Cord Stimulator (SCS) System.
P030022/S020
1/20/12
Reflection Ceramic Hip System Smith & Nephew, Inc.
Memphis, TN
38116
Change in the hip stem coating process.
P040044/S042
1/6/12
Mynx Vascular Closure Device Product Family Access Closure, Inc.
Mountain View, CA
94043
Change to the freeze-dry process and equipment.
P050012/S043
1/18/12
Dexcom™ SEVEN® and SEVEN PLUS® Continuous Glucose Monitoring Systems Dexcom, Inc.
San Diego, CA
92121
Change in a manufacturing fixture used in the attachment of an adhesive patch in the Sensor/ Applicator Delivery System component in the SEVEN® and SEVEN PLUS® Continuous
Glucose Monitoring Systems. Additionally, the mechanical instron pull test was replaced with a
manual adhesive patch pull test to be used in Receiving inspection for the disposable housing of the SEVEN® and SEVEN PLUS® Continuous Glucose Monitoring Systems.
P060001/S016
1/18/12
Protègè GPS and Protègè RX Carotid Stent Systems Ev3, Inc.
Plymouth, MN
55441
Addition of a 7-pallet sterilizer vessel at the contract sterilizer.
P060002/S023
1/18/12
Bard FLAIR Endovascular Stent Graft Bard Peripheral Vascular, Incorporated
Tempe, AZ
85281
Use of an alternate ink on the delivery system handle.
P060007/S017
1/13/12
ARCHITECT HBsAg and HBsAg Confirmatory Abbott Laboratories
Abbott Park, IL
60064
Change to a quality control test method used for bioburden evaluation.
P060027/S035
1/11/12
Paradym CRT-D Sorin CRM USA, Inc.
Plymouth, MN
55441
In-sourcing of an electronic assembly.
P070015/S085
1/20/12
XIENCE V Everolimus-Eluting Coronary Stent System and XIENCE nano Everolimus-Eluting Coronary Stent System/PROMUS Everolimus-Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92591
Addition of an alternate manufacturing site for drug sublotting and the implementation of a new piece of equipment for pouch sealing.
P080004/S010
1/20/12
Hoya iSpheric Hoya Surgical Optics, Inc.
Chino Hills, CA
91709
Change to the incubation time of the Biological Indicator.
P080014/S010
1/20/12
Cervista® Human Papilloma Virus (HPV) High Risk (HR) Hologic, LP
Marlborough, MA
01752
Change to replace quality control test method controls with new quality control test method controls from the same supplier for incoming materials inspection testing and in-process quality control testing of accessory kit reagents.
P080025/S024
1/13/12
InterStim Leads Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of two new desktop welding stations with updated power supplies, and two process changes to include the consolidation of production laser weld program code and reducing frequency parameters for the welding process.
P080025/S025
1/20/12
InterStim II Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Thermal processing of Eccobond epoxy resin E3450(A) prior to consumption in routine manufacturing.
P080025/S026
1/30/12
Interstim Sacral Nerve Stimulation Therapy System, Test Stimulation Lead and Test Stimulation Lead Kit Medtronic Neuromodulation
Minneapolis, MN
55432
Alternate supplier for a process for coating conductor wire.
P090013/S049
1/18/12
Revo MRI IPGs Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing component used during routine manufacturing.
P100010/S013
1/13/12
Freezor® MAX Cardiac CryoAblation Catheter Medtronic CryoCath LP
Pointe Claire, Quebec, Canada
H9R SZ8
Streamlining the inspection procedure for the Freezor® family of catheters.
P100023/S031
1/20/12
ION (TAXUS Element) Paclitaxel- Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Addition of an alternative combination mandrel for welding during assembly.
P100023/S032
1/25/12
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Use of a new statistical analysis software package in the manufacturing process.
P100041/S003
1/19/12
Edwards SAPIEN Transcatheter Heart Valve Edwards Lifesciences, Inc.
Irvine, CA
92614
Addition of Hawkins Inc., as an alternate supplier of sodium chloride.
P100041/S004
1/18/12
Edwards SAPIEN Transcatheter Heart Valve Edwards Lifesciences, Inc.
Irvine, CA
92614
Additional supplier of bovine tissue.
P110010/S003
1/13/12
PROMUS Element Plus Platinum Chromium Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P110019/S006
1/18/12
XIENCE PRIME EECSS and XIENCE PRIME LL ECSS Abbot Vascular
Temecula, CA
92591
Remove redundant cleaning and treatment steps and include cleanroom process modifications.
P110019/S007
1/18/12
XIENCE PRIME and XIENCE PRIME LL Everolimus-Eluting Coronary Stent Systems Abbott Vascular
Temecula, CA
92591
Manufacturing change to automate the adaption cup preparation process.
P110019/S008
1/20/12
XIENCE PRIME Everolimus-Eluting Coronary Stent System and XIENCE PRIME LL Everolimus-Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92591
Addition of an alternate manufacturing site for drug sublotting and the implementation of a new piece of equipment for pouch sealing.

Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 48

Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 33
Total On Hold: 46
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 559
Total Active: 412
Total On Hold: 147
Number Greater Than 180 Days: 8

Summary of All PMA Submissions Received
Originals: 1
Supplements: 71

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 48
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 248.7
FDA Time: 159.9 Days MFR Time: 84.9 Days