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U.S. Department of Health and Human Services

Medical Devices

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December 2011 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P100046
12/14/11
AtriCure Synergy Ablation SystemBoston Biomedical Associates, LLC
Northborough, MA
01532
Approval for the AtriCure Synergy Ablation System. This device is indicated for the ablation of cardiac tissue for the treatment of persistent atrial fibrillation (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion) or longstanding persistent atrial fibrillation (continuous atrial fibrillation of greater than one year duration) in patients who are undergoing open concomitant coronary artery bypass grafting and/or valve replacement or repair.
P110025
12/14/11
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgMRoche Diagnostics
Indianapolis, IN
46250
Approval for the Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the MODULAR ANAL YTICS E170 Immunoassay Analyzer. This device is indicated for:
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 electrochemiluminescence immunoassay "ECLIA" is intended for use on the MODULAR ANAL YTICS E170 immunoassay analyzer. Elecsys PreciControl Anti-HBc IgM is used for quality control of the Elecsys Anti-HBc IgM immunoassay on the MODULAR ANAL YTICS E170 immunoassay analyzer. (correction will need to be entered into database)

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P820003/S114
12/21/11
Real-Time
External Pulse GeneratorsMedtronic, Inc.
Cardiac Rhythm Disease Management
Mounds View, MN
55112
Approval for components changing from Lead-Containing to Lead-Free used in the Medtronic 2090 Programmer, 5388 Dual Chamber EPG, and 5348 Single Chamber EPG.
P820060/S030
12/22/11
135-Day
AxSYM AFPAbbott Laboratories Diagnostics Division
Abbott Park, IL
60064
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
P850079/S050
12/20/11
180-Day
ClearSoft (methafilcon A) Soft Contact Lens for Extended WearCooper Vision, Inc.
Pleasanton, CA
94588
Approval to add the private label name AquaTech Premium to the list of approved name for the device.
P860004/S136
12/15/11
Real-Time
InDura 1 Piece Intrathecal Catheter with Sutureless Connector, Intrathecal Catheter Pump Segment Revision Kit with sutureless connector, and Sutureless Pump Connector Revision KitMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for the following minor design changes: 1) Model 8709SC InDura 1 Piece Intrathecal Catheter with sutureless connector; 2) Model 8731SC Intrathecal Catheter with sutureless connector; 3) Model 8596SC Intrathecal Catheter Pump Segment Revision Kit with sutureless connector; and 4) Model 8578 Sutureless Pump Connector Revision Kit for Model 8709 and Model 8709SC Intrathecal Catheters.
P860004/S158
12/9/11
Real-Time
SynchroMed II Programmable PumpMedtronic, Inc.
Minneapolis, MN
55432
Approval for the following: 1) The assembly process for the roller subcomponent of the pumphead currently uses a manual press and will be changed to use a motorized press that monitors and controls travel distance and assembly force. This change is intended to improve yield and manufacturing efficiency; 2) The manufacturing tolerance for the non-critical dimension for the pumphead assembly defined as the "stop position" will be changed from 10.77 + 0.044/-0.046 millimeters to10.77 +/-0.060 millimeters. The critical component specification of force applied by the pumphead rollers on the pump tube is not changing. This change is intended to improve yield of the pumphead component; and 3) The manufacturing tolerance for the non-critical dimension for rivet diameter used to assemble the support roller arm sides and support roller arm center in the pumphead assembly will be changed from 1 +/ -0.002 millimeters to 1 +/-0.006 millimeters. The rivets will also be sorted based on the individual diameter to match with the diameter of the holes in the assembly they are inserted into to prevent interference. The critical component specification of minimum press out force after the rivet is pressed into place is not changing. This change is intended to improve yield of the pumphead component.
P870072/S046
12/21/11
180-Day
Thoratec VAD SystemThoratec Corporation
Pleasanton, CA
94588
Approval for a manufacturing site located at Thoratec Corporation in San Ramon,
California for receiving acceptance activities, receiving inspection, warehousing, and shipping operations.
P890003/S238
12/6/11
Real-Time
CareLink Remote Home Monitor/ CardioSight Reader/CareLink Express MonitorMedtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Medtronic CardioSight Reader and Model 2020B CareLink Express Monitor.
P890003/S242
12/21/11
Real-Time
CareLink ProgrammerMedtronic, Inc.
Cardiac Rhythm Disease Management
Mounds View, MN
55112
Approval for components changing from Lead-Containing to Lead-Free used in the Medtronic 2090 Programmer, 5388 Dual Chamber EPG, and 5348 Single Chamber EPG.
P900060/S041
12/21/11
Real-Time
Carbomedics Prosthetic Heart Valve™,
Carbo-Seal® Ascending Aortic Prosthesis, and Carbo-Seal® Valsalva Ascending Aortic Prosthesis
Sorin Group USA, Inc.
Arvada, CO
80004
Approval to extend the magnetic resonance imaging (MRI) compatibility from 1.5 Tesla to 3.0 Tesla and to incorporate other labeling revisions for the purpose of unifying and rebranding the US market labels with other, non-US market labels.
P900061/S109
12/23/11
135-Day
Oval Patch Lead ModelsMedtronic, Inc.
Mounds View, MN
55112
Approval for the relocation of a Controlled Environment Area (CEA).
P910001/S050
12/6/11
Real-Time
CVX-300 Excimer Laser SystemSpectranetics, Corporation
Colorado Springs, CO
80921
Approval to implement a change to the radio frequency (RF) absorption materials for the CVX-300P model excimer laser.
P910007/S032
12/22/11
135-Day
AxSYM Total PSAAbbott Laboratories Diagnostics Division
Abbott Park, IL
60064
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
P910007/S033
12/21/11
Special
Architect Free PSAAbbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for a change in the quality control testing of an incoming raw material used for manufacturing the device and it’s finished accessory.
P920014/S031
12/21/11
180-Day
HeartMate
XVE LVAS
Thoratec Corporation
Pleasanton, CA
94588
Approval for a manufacturing site located at Thoratec Corporation in San Ramon,
California for receiving acceptance activities, receiving inspection, warehousing, and shipping operations.
P950032/S066
12/28/11
Real-Time
Apligraf (Graftskin)Organogenesis, Inc.
Canton, MA
02021
Approval for the introduction of a new fibroblast cell strain (HDF 167) in the commercial production of Apligraf.
P950037/S099
12/2/11
Real-Time
TILDA Family of Pacing LeadsBiotronik, Inc.
Lake Oswego, OR
97035
Approval for additional trade names for the Selox, Setrox and Corox families of pacing leads.
P970003/S140
12/20/11
Real-Time
VNS Therapy System AspireHCCyberonics
Houston, TX
77058
Approval for :
1) Removal of the CR10 and CR11 TVS diodes from the PCBA design; and 2) A change to the printed circuit board (PCB) specification to accept vias (vertical electrical connections between different layers of conductors on a PCB) filled with epoxy from the PCB vendor, which is currently allowed for the Model 103/104 Pulse Generators.
P970008/S058
12/9/11
180-Day
Urologix Targis® System for the Treatment of BPHUrologix, Inc.
Minneapolis, MN
55447
Approval for device and manufacturing modifications of the tip of the CTC Advanced Catheter component of the Targis® System.
P970027/S017
12/22/11
135-Day
AxSYM Anti-HCVAbbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
P970051/S086
12/2/11
135-Day
Nucleus Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Approval to use the same chip and bonding material employed in the design of the CP180 Sound Processor in the Freedom Sound Processor.
P970051/S088
12/20/11
Real-Time
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Approval for a modified version of the approved CP800 series coil to accommodate the magnet strength of 6 that is higher than the strengths currently available.
P980007/S023
12/22/11
135-Day
AxSYM Free PSAAbbott Laboratories Diagnostics Division
Abbott Park, IL
60064
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
P980007/S024
12/21/11
Special
Architect Free PSAAbbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for a change in the quality control testing of an incoming raw material used for manufacturing the device and it’s finished accessory.
P980016/S327
12/6/11
Real-Time
Entrust/Intrinsic/ Marquis/Maximo/ Maximo II/Secura/ Virtuoso II/InSync Marquis/Virtuoso/ ProtectaMedtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Medtronic CardioSight Reader and Model 2020B CareLink Express Monitor.
P980022/S075
12/20/11
180-Day
Paradigm
Real-Time System
Medtronic, Inc.
Northridge, CA
91325
Approval for the MySentry System, which includes a Monitor/ (MMT-9101) and a
remote Outpost (MMT-9102), for use with the Paradigm Real-Time System. The new manufacturing facility for the MySentry System is Flextronics Industrial (Shenzhen) Co., Ltd., located in Shenzhen,
China .
P980022/S099
12/20/11
Real-Time
Medtronic MiniMed Continuous Glucose Monitoring SystemMedtronic, Inc.
Northridge, CA
91325
Approval for software changes to the CareLink Personal Therapy Management Software for Diabetes MMT-7333 v5.7A for use with the device.
P980022/S101
12/28/11
Real-Time
Medtronic MiniMed Continuous Glucose Monitoring SystemMedtronic, Inc.
Northridge, CA
91325
Approval for the glass-lidded crystal to be replaced with a ceramic lidded crystal on the digital board in the Gold monitor (model MMT-7102W), which is a component of the device.
P980035/S249
12/6/11
Real-Time
Advisa/EnRhythmMedtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Medtronic CardioSight Reader and Model 2020B CareLink Express Monitor.
P990071/S009
12/21/11
180-Day
ThermoCool SF CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval for the following modifications:
1) Reduced recommended saline flow rate (reduce by ~50%; 2) Increase in number of irrigation holes (from 6 to 56); 3) Decrease in size of irrigation holes (from 0.016” to 0.0035” diameter); 4) Modified tip electrode material (from 90% Platinum/10% Iridium to 80% Palladium/20% Platinum); and 5) Update Stockert 70 RF Generator Software (v1.35 to v1.037).
The device, as modified will be marketed under the trade names Bi-directional Carto XP ThermoCool SF Nav Catheter, Bi-directional Carto 3 ThermoCool SF Nav Catheter, and Bi-directional ThermoCool SF Catheter and is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RT generator, for the treatment of: a) Type I atrial flutter in patients age 18 or older; and b) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The Biosense Webster ThermoCool SF Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF Generator, for the treatment of Type I atrial flutter in patients age 18 or older.
P990071/S013
12/21/11
180-Day
ThermoCool SF CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval for the following modifications:
1) Reduced recommended saline flow rate (reduce by ~50%; 2) Increase in number of irrigation holes (from 6 to 56); 3) Decrease in size of irrigation holes (from 0.016” to 0.0035” diameter); and 4) Modified tip electrode material (from 90% Platinum/10% Iridium to 80% Palladium/20% Platinum).
The device, as modified will be marketed under the trade names Uni-directional Carto XP ThermoCool SF Nav Catheter, Uni-directional Carto 3 ThermoCool SF Nav Catheter, and Uni-directional ThermoCool SF Catheter and is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RT generator, for the treatment of: a) Type I atrial flutter in patients age 18 or older; and b) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The ThermoCool SF Nav Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with compatible Carto EP Navigation Systems. The Biosense Webster ThermoCool SF Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF Generator, for the treatment of Type I atrial flutter in patients age 18 or older.
P000008/S026
12/9/11
Real-Time
LAP-BAND® Adjustable Gastric Banding (LAGB) SystemAllergan, Inc.
Goleta, CA
93117
Approval for an alternate hub material on the 3.5 inch and 2.0 inch Access Port Needles used with the LAP-BAND System.
P000010/S022
12/29/11
180-Day
AMPLICOR® HCV Test, v2.0Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey.
P000012/S031
12/29/11
180-Day
COBAS AMPLICOR™ HCV Test v2.0 and COBAS AmpliPrep/ COBAS Amplicor HCV Test v2.0Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey.
P000025/S059
12/16/11
Real-Time
MED-EL Cochlear Implant SystemsMED-EL Corp.
Durham, NC
27713
Approval for the OPUS 2 Battery Pack XS which is an additional optional battery pack for use with the following approved audio processors of the MED-EL Cochlear Implant (CI) System: TEMPO+, OPUS 1 and OPUS 2.
P000058/S045
12/23/11
Special
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek
Memphis, TN
38132
Approval for modification to the adverse event reporting table in the package insert due to identification of transposition and typographical errors.
P010013/S042
12/20/11
Real-Time
NovaSure Impedance Controlled Endometrial Ablation SystemHologic, Inc.
Marlborough, MA
01752
Approval for a change to the NovaSure to add the SureSound uterine sound to the existing thermoformed tray for the NovaSure disposable device.
P010015/S145
12/6/11
Real-Time
Consulta CRT-P/ Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Medtronic CardioSight Reader and Model 2020B CareLink Express Monitor.
P010031/S280
12/6/11
Real-Time
Concerto II/Consulta/
InSync II Marquis/InSync Marquis III/InSync Maximo/InSync Sentry/Maximo II/Protecta/
Protecta XT/InSync Marquis/InSync II Protect/Concerto
Medtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Medtronic CardioSight Reader and Model 2020B CareLink Express Monitor.
P010047/S010
12/21/11
180-Day
ProGel™ Pleural Air Leak SealantNeoMend, Inc.
Irvine, CA
92618
Approval for the ProGel™ Applicator Extended Spray Tips as an accessory for the ProGel™ Pleural Air Leak Sealant. The device, as modified, will be marketed under the trade name ProGel™ Applicator Extended Spray Tips and the indications for use is to deliver ProGel™ to visceral pleura during an open thoracotomy after standard visceral pleural closure (i.e. with sutures or staples) of visible air leaks (≥ 2 mm) incurred during open resection of lung parenchyma in adult humans by bending the malleable tip to direct ProGel™ from the delivery tip in a stream or spray cone pattern that is perpendicular to the target surface.
P020018/S041
12/14/11
180-Day
Zenith Flex AAA Endovascular Graft SystemCook, Inc.
Bloomington, IN
47402
Approval for modifications to the ancillary component’s delivery systems for the Zenith Flex AAA Endovascular Graft product line.
P020036/S021
12/5/11
180-Day
S.M.A.R.T. Control® Nitinol Stent SystemCordis Corporation Somerville, NJ
08876
Approval for a change in the material composition of the tubing in the Hemostasis Valve.
P030019/S014
12/30/11
180-Day
OrthoviscAnika Therapeutics, Inc.
Bedford, MA
01730
Approval for a manufacturing site located in Bedford, Massachusetts.
P030023/S001
12/14/11
180-Day
Ophtec Capsular Tension RingOphtec USA, Inc.
Boca Raton, FL
33487
Approval for a trade name change. The device, as modified, will be marketed under the trade name Ophtec Capsular Tension Ring Models 276 and 275 and is indicated for the stabilization of weakened, broken or missing zonules that are suspected or observed during cataract extraction using phacoemulsification and continuous curvilinear capsulorhexis techniques in adults.
P030031/S025
12/21/11
180-Day
ThermoCool SF CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval for the following modifications:
1) Reduced recommended saline flow rate (reduce by ~50%; 2) Increase in number of irrigation holes (from 6 to 56); 3) Decrease in size of irrigation holes (from 0.016” to 0.0035” diameter); 4) Modified tip electrode material (from 90% Platinum/10% Iridium to 80% Palladium/20% Platinum); and 5) Update Stockert 70 RF Generator Software (v1.35 to v1.037).
The device, as modified will be marketed under the trade names Bi-directional Carto XP ThermoCool SF Nav Catheter, Bi-directional Carto 3 ThermoCool SF Nav Catheter, and Bi-directional ThermoCool SF Catheter and is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RT generator, for the treatment of: a) Type I atrial flutter in patients age 18 or older; and b) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The Biosense Webster ThermoCool SF Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF Generator, for the treatment of Type I atrial flutter in patients age 18 or older.
P030031/S034
12/21/11
180-Day
ThermoCool SF CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval for the following modifications:
1) Reduced recommended saline flow rate (reduce by ~50%; 2) Increase in number of irrigation holes (from 6 to 56); 3) Decrease in size of irrigation holes (from 0.016” to 0.0035” diameter); and 4) Modified tip electrode material (from 90% Platinum/10% Iridium to 80% Palladium/20% Platinum).
The device, as modified will be marketed under the trade names Uni-directional Carto XP ThermoCool SF Nav Catheter, Uni-directional Carto 3 ThermoCool SF Nav Catheter, and Uni-directional ThermoCool SF Catheter and is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RT generator, for the treatment of: a) Type I atrial flutter in patients age 18 or older; and b) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The ThermoCool SF Nav Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with compatible Carto EP Navigation Systems. The Biosense Webster ThermoCool SF Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF Generator, for the treatment of Type I atrial flutter in patients age 18 or older.
P030031/S036
12/12/11
Real-Time
NAVISTAR® RMT THERMOCOOL® Diagnostic/Ablation Steerable Tip CatheterBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval for extending the shelf life from one (1) to three (3) years and for a minor change to the thermofoam tray used to package the devices.
P030050/S009
12/9/11
Real-Time
Sculptra and Sculptra AestheticSanofi-aventis, U.S. LLC
Bridgewater, NJ
08807
Approval for: 1) a revision of Sculptra and Sculptra Aesthetic labeling to include information concerning a preclinical imaging study completed as Condition of Approval; and 2) revision of the storage conditions presented in your product label.
P040002/S035
12/6/11
Real-Time
AFX AAA Endovascular SystemEndologix, Inc.
Irvine, CA
92618
Approval for a modified contralateral limb SurePass guidewire holder. The device, as modified, will be marketed under the trade name AFX AAA Endovascular System and is indicated for endovascular treatment in patients with AAA.
P040003/S010
12/8/11
180-Day
ExAblateInSightec, Inc.
Dallas, TX
75244
Approval for modification of the ExAblate platform:
1) so that the same
platform can be used with multiple cradles; and 2) to enable the cradle that has the capability to
move the transducer in the anterior and posterior directions be used in the locked position for
commercial uterine fibroid treatment.
P040013/S017
12/6/11
180-Day
GEM21S Growth Factor Enhanced MatrixLuitpold Pharmaceuticals, Inc.
Valley Forge, PA
19403
Approval of the post-approval study protocol.
P040021/S016
12/22/11
180-Day
Biocor, Biocor Supra, Epic and Epic Supra Prosthetic Heart ValvesSt. Jude Medical
St. Paul, MN
55117
Approval for an additional sterilization site and for final packaging operations located at St. Jude Medical, Pampulha, Brazil.
P040021/S019
12/19/11
135-Day
EPIC ValvesSt. Jude Medical
St. Paul, MN
55117
Approval for changes in the exposure times to sterilant and manufacturing process solutions.
P040023/S019
12/20/11
Special
Duraloc Option® Ceramic Hip SystemDePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for visual inspection of the Duraloc Option porous acetabular shells.
P040034/S020
12/16/11
135-Day
DuraSeal Dural Sealant SystemConfluent Surgical, Inc., DBA Covidien
Bedford, MA
01730
Approval for the addition of a scan height range for the irradiation beam at the sterilization vendor.
P040036/S018
12/21/11
180-Day
ThermoCool SF CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval for the following modifications:
1) Reduced recommended saline flow rate (reduce by ~50%; 2) Increase in number of irrigation holes (from 6 to 56); 3) Decrease in size of irrigation holes (from 0.016” to 0.0035” diameter); 4) Modified tip electrode material (from 90% Platinum/10% Iridium to 80% Palladium/20% Platinum); and 5) Update Stockert 70 RF Generator Software (v1.35 to v1.037).
The device, as modified will be marketed under the trade names Bi-directional Carto XP ThermoCool SF Nav Catheter, Bi-directional Carto 3 ThermoCool SF Nav Catheter, and Bi-directional ThermoCool SF Catheter and is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RT generator, for the treatment of: a) Type I atrial flutter in patients age 18 or older; and b) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The Biosense Webster ThermoCool SF Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF Generator, for the treatment of Type I atrial flutter in patients age 18 or older.
P040036/S025
12/21/11
180-Day
ThermoCool SF CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval for the following modifications:
1) Reduced recommended saline flow rate (reduce by ~50%; 2) Increase in number of irrigation holes (from 6 to 56); 3) Decrease in size of irrigation holes (from 0.016” to 0.0035” diameter); and 4) Modified tip electrode material (from 90% Platinum/10% Iridium to 80% Palladium/20% Platinum).
The device, as modified will be marketed under the trade names Uni-directional Carto XP ThermoCool SF Nav Catheter, Uni-directional Carto 3 ThermoCool SF Nav Catheter, and Uni-directional ThermoCool SF Catheter and is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RT generator, for the treatment of: a) Type I atrial flutter in patients age 18 or older; and b) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The ThermoCool SF Nav Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with compatible Carto EP Navigation Systems. The Biosense Webster ThermoCool SF Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF Generator, for the treatment of Type I atrial flutter in patients age 18 or older.
P040036/S027
12/12/11
Real-Time
CELSIUS® RMT THERMOCOOL®Diagnostic/Ablation Steerable Tip CatheterBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval for extending the shelf life from one (1) to three (3) years and for a minor change to the thermofoam tray used to package the devices.
P040043/S041
12/21/11
135-Day
Gore TAG Thoracic EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86003
Approval for modification to the sampling plan for fatigue testing.
P050028/S019
12/29/11
180-Day
COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test v2.0 and COBAS TaqMan HBV Test v2.0Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey.
P050042/S015
12/21/11
Special
Architect Anti-HCVAbbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for a change in the quality control testing used on an incoming raw material and a finished accessory used in the device.
P050049/S009
12/22/11
135-Day
AxSYM HBsAg and HBsAg ConfirmatoryAbbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
P050051/S014
12/21/11
Special
Architect AUSABAbbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for a change in the quality control testing used on an incoming raw material and a finished accessory used in the device.
P060003/S011
12/22/11
135-Day
AxSYM AUSABAbbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
P060007/S016
12/21/11
Special
Architect HBsAg and Architect HBsAg Confirmatory AssaysAbbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for a change in the quality control testing used on an incoming raw material and a finished accessory used in the device.
P060009/S006
12/22/11
135-Day
AxSYM CORE-M 2.0Abbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
P060012/S009
12/22/11
135-Day
AxSYM CORE 2.0Abbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
P060030/S020
12/29/11
180-Day
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test v2.0 and COBAS TaqMan HCV Test v2.0Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey.
P060035/S013
12/21/11
Special
Architect CORE-MAbbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for a change in the quality control testing used on an incoming raw material and a finished accessory used in the device.
P060037/S014
12/21/11
135-Day
NexGen® Complete Knee LPS and LPS-Flex Mobile Bearing KneeZimmer, Inc.
Warsaw, IN
46581
Approval for the addition of a new compression molding press by the raw material supplier.
P060038/S010
12/12/11
135-Day
Mitroflow Aortic Pericardial Heart ValveSorin Group USA, Inc.
Arvada, CO
80004
Approval for implementation of an in-house distillation process to produce EM Grade Glutaraldehyde to be used in the manufacture of the subject device.
P060040/S014
12/21/11
180-Day
HeartMate II LVASThoratec Corporation
Pleasanton, CA
94588
Approval for a manufacturing site located at Thoratec Corporation in San Ramon,
California for receiving acceptance activities, receiving inspection, warehousing, and shipping operations.
P070001/S010
12/22/11
135-Day
ProDisc-C Total Disc ReplacementSynthes Spine
West Chester, PA
19380
Approval for an additional perthometer and complimenting software.
P070008/S027
12/2/11
Real-Time
CELERITY Family of Left Ventricular Pacing LeadsBiotronik, Inc.
Lake Oswego, OR
97035
Approval for additional trade names for the Selox, Setrox and Corox families of pacing leads.
P070016/S006
12/6/11
180-Day
Zenith TX2 TAA Endovascular Graft with the H&L-B One Shot™ Introduction SystemCook, Inc.
West Lafayette, IN
47906
Approval of the post-approval study protocol.
P080011/S005
12/20/11
180-Day
Biofinity (Comfilcon A) Soft Contact Lens for Extended WearCooper Vision, Inc.
Pleasanton, CA
94588
Approval to add the private label name AquaTech Plus Premium to the list of approved names for the device.
P080014/S007
12/12/11
180-Day
 
Cervista® HPV HR High-Throughput AutomationHologic, Inc.
Marlborough, MA
01752
Approval for migration of the Cervista® HPV HR manual assay to an automated platform High-Throughput Automation. The device, as modified, will be marked under trade name Cervista® HPV HR High-Throughput Automation and is indicated for:
The Cervista® HPV HR test is an in vitro diagnostic test for the qualitative detection of DNA from 14 high-risk Human Papillomavirus (HPV) types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,
59, 66, and 68) in cervical specimens. The Cervista® HPV HR test cannot determine the specific HPV type present.
The Cervista® HPV HR test uses the Invader® chemistry, a signal amplification method for detection of specific nucleic acid sequences. This method uses two types of isothermal reactions: a primary reaction that occurs on the targeted DNA sequence and a secondary reaction that produces a fluorescent signal.
The Cervista® HPV HR test is indicated:
1) To screen patients with atypical squamous cells of undetermined significance
(ASCUS) cervical cytology results to determine the need for referral to colostomy; and 2) In women 30 years and older the Cervista® HPV HR 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. Cervical specimens that may be tested with the Cervista® HPV HR test include the following
preservation system collection media and collection devices:
• ThinPrep® Pap Test PreservCyt® Solution
• Broom-type device (e.g., Rovers Cervex Brush, Wallach Papette), or Endocervical
Brush/Spatula.
The Cervista® HPV HR test may be performed either manually or using the automated Cervista®
High-Throughput Automation system. (Corrected statement needs to be added to database.)
P080023/S012
12/21/11
Special
Architect COREAbbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Approval for a change in the quality control testing used on an incoming raw material and a finished accessory used in the device.
P090013/S044
12/6/11
Real-Time
Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490G Medtronic CareLink Remote Home Monitor, Model 2020A Medtronic CardioSight Reader and Model 2020B CareLink Express Monitor.
P090022/S007
12/20/11
135-Day
Softec HD, Softec I and Softec HD PS Intraocular LensesLenstec, Inc,
St. Petersburg, FL
33716
Approval of a new lens analyzer.
P100020/S001
12/29/11
180-Day
COBAS HPV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey.
P100023/S003
12/15/11
180-Day
ION Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval of the post-approval study protocol.
 
P100028/S001
12/5/11
180-Day
Formula Balloon- Expandable Renal StentCook Medical, Inc. Bloomington, IN
47402
Approval of the post-approval study protocol.
P100029/S003
12/22/11
180-Day
Trifecta Heart ValvesSt. Jude Medical
St. Paul, MN
55128
Approval for an additional sterilization site and for final packaging operations located at St. Jude Medical, Pampulha, Brazil.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N12159/S029
12/21/11
Surgicel Absorbable HemostatsEthicon, Inc.
Somerville, NJ
08876
Addition of a new cutter for the Surgicel Absorbable Hemostat raw material.
N18033/S062
12/2/11
Vistakon
(etafilcon A) Brand Contact Lenses
Johnson &Johnson Vision Care, Inc. Jacksonville, FL
32256
Change in finished goods parameter testing.
N18033/S063
12/15/11
Vistakon
(etafilcon A) Brand Contact Lenses
Johnson &Johnson Vision Care, Inc. Jacksonville, FL
32256
Change to the sensors.
 
P830061/S074
12/19/11
CapSureMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P840001/S198
12/12/11
Spinal Cord StimulationMedtronic Neuromodulation
Minneapolis, MN
55432
Relocation of passivation operations and introduction of an automated fluid transfer process within the existing Medtronic Neuromodulation facility – Rice Creek Central.
P840001/S200
12/28/11
SCS Neurostimulator External, RestorePrime®, PrimeAdvanced®, Restore®, RestoreUltra®, RestoreAdvanced® and RestoreSensor®Medtronic Neuromodulation
Minneapolis, MN
55432
Upgrade and use version 6.4 of the Hybrid Slant Handler Software at Medtronic’s hybrid supplier.
P850089/S086
12/19/11
CapSure Z NovusMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P860004/S162
12/12/11
Implantable Infusion SystemMedtronic Neuromodulation
Minneapolis, MN
55432
Relocation of passivation operations and introduction of an automated fluid transfer process within the existing Medtronic Neuromodulation facility – Rice Creek Central.
P860004/S164
12/7/11
SynchroMed Refill Kit and Catheter Access Port KitMedtronic Neuromodulation
Minneapolis, MN
55432
Updating of the sterilant ethylene oxide residual parameter.
P860004/S166
12/28/11
SynchroMed IIMedtronic Neuromodulation
Minneapolis, MN
55432
Upgrade and use version 6.4 of the Hybrid Slant Handler Software at Medtronic’s hybrid supplier.
P860057/S081
12/12/11
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthetic ValveEdwards Lifesciences, LLC
Irvine, CA
92614
New cleaning method for mold inserts.
P870056/S044
12/12/11
Carpentier-Edwards Porcine Bioprosthetic ValveEdwards Lifesciences, LLC
Irvine, CA
92614
New cleaning method for mold inserts.
P870077/S040
12/12/11
Carpentier-Edwards Duraflex Low Pressure BioprosthesisEdwards Lifesciences, LLC
Irvine, CA
92614
New cleaning method for mold inserts.
P880047/S018
12/14/11
Gynecare Interceed Absorbable Adhesion BarrierEthicon, Inc.
Somerville, MN
08876
Addition of new equipment.
P880086/S213
12/30/11
Family of Pacemaker DevicesSt. Jude Medical, Inc.
Sylmar, CA
91342
Alternate supplier for the thin film resistor component.
P890003/S239
12/7/11
CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Manufacturing changes to accommodate an equivalent part addition.
P890003/S241
12/19/11
CapSureMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P900056/S110
12/5/11
Rotablator Rotational Angioplasty System Guidewire with wireClip TorquerBoston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P900056/S111
12/5/11
Rotablator Rotational Atherectomy SystemBoston Scientific Corporation
Maple Grove, MN
55311
Addition of an alternate resin for the sealing of Tyvek tray lids.
P910001/S052
12/27/11
ELCA Coronary Atherectomy CathetersSpectranetics Corporation
Colorado Springs, CO
80921
Change in EO sterilization process monitoring.
P910023/S280
12/1/11
Fortify ICDSt. Jude Medical
Sylmar, CA
91342
Addition of an alternate supplier.
 
P910023/S282
12/30/11
Family of ICD DevicesSt. Jude Medical, Inc.
Sylmar, CA
91342
Alternate supplier for the thin film resistor component.
P920015/S085
12/19/11
Sprint Quattor, Subcutaneous LeadMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P920023/S030
12/14/11
AMS UroLume EndoprosthesisAmerican Medical Systems
Minnetonka, MN
55343
Change in a measurement method used during the post sterile packaging operation.
P920047/S050
12/5/11
Blazer II XP Cardiac Ablation Catheter/Cable/ Blazer II High Torque Distal (HTD) Ablation Catheter/Cable/ Blazer Prime HTD Ablation Catheter/ CableBoston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P930029/S035
12/23/11
Atakr RF Catheter SystemMedtronic, Inc.
Mounds View, MN
55112
Implementation of the new electrical test systems.
P930039/S065
12/19/11
CapSure, SureFixMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P940008/S028
12/23/11
Lead Cap KitBoston Scientific CRM
St. Paul, MN
55112
Addition of an alternate second source supplier for accessories to implantable leads.
P950005/S036
12/23/11
EZ Steer Bi-Directional Non-Nav THR Catheter, EZ Steer Bi-Directional
Non-Nav TC Catheter, EZ Steer Bi-Directional Non-Nav DS Catheter
Biosense Webster, Inc.
Diamond Bar, CA
91765
Additional rework process.
P950020/S047
12/7/11
Coronary Flextome Cutting BalloonBoston Scientific Corporation
Maple Grove, MN
55311
Change to the manufacturing process equipment by implementing an alternate bioslide coating machine, with updated hardware, software, and processing changes, as well as a
minor rearrangement of the existing production equipment to new locations within the current manufacturing line.
P950024/S039
12/19/11
CapSure Epicardial Pacing LeadMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P960009/S132
12/12/11
Deep Brain Stimulation (DBS)Medtronic Neuromodulation
Minneapolis, MN
55432
Relocation of passivation operations and introduction of an automated fluid transfer process within the existing Medtronic Neuromodulation facility – Rice Creek Central.
P960009/S133
12/28/11
Activa® PC, Activa SC, Activa RC and DBS Neurostimulator ExternalMedtronic Neuromodulation
Minneapolis, MN
55432
Upgrade and use version 6.4 of the Hybrid Slant Handler Software at Medtronic’s hybrid supplier.
P960016/S038
12/20/11
Livewire TC and Safire Ablation CathetersSt. Jude Medical
Minnetonka, MN
55345
User of an additional sterilization chamber.
P960042/S033
12/27/11
Spectranetics Laser SheathsSpectranetics Corporation
Colorado Springs, CO
80921
Change in EO sterilization process monitoring.
D970003/S133
12/5/11
INSIGNIA and ALTRUA Families of PacemakersBoston Scientific CRV
St. Paul, MN
55112
Addition of multiple pieces of manufacturing equipment already in use on other product lines.
P970003/S141
12/2/11
VNS Therapy® WandCyberonics, Inc.
Houston, TX
77058
Addition of a rework step for soldering operations of light emitting diodes (LEDs) to printed circuit boards (PCBs).
P970003/S142
12/23/11
VNS Therapy® SystemCyberonics, Inc.
Houston, TX
77058
Two revisions to the software used in the Automated Functional Test System (AFT) for the VNS Therapy System Pulse Generators.
P970004/S126
12/28/11
InterStim® IIMedtronic Neuromodulation
Minneapolis, MN
55432
Upgrade and use version 6.4 of the Hybrid Slant Handler Software at Medtronic’s hybrid supplier.
P970029/S018
12/16/11
Transmyocardial Revascularization Laser SystemCryoLife, Inc.
Cardiogenesis
Kennesaw, GA
30144
Changes to the manufacturing of the handpiece delivery system.
P970055/S012
12/29/11
Parvovirus B19 IgM Enzyme ImmunoassayBiotrin International Ltd.
Dublin, Ireland
Manufacturing location and QC testing sequence changes for Streptavidin-HRP substrate.
P980003/S033
12/5/11
Chilli II Cooled Ablation Catheter and CableBoston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P980016/S328
12/13/11
Maximo II, Protecta, Protecta XT, Secura and Virtuoso IIMedtronic, Inc.
Mounds View, MN
55112
Updated version of software which supports the Hybrid Slant Handler used for testing of hybrid subassemblies.
P980016/S330
12/14/11
Protecta and Protecta XT Families of ICDsMedtronic, Inc.
Mounds View, MN
55112
Multiple test method updates to a radiofrequency test application.
P980016/S332
12/23/11
EnTrust, Maximo II, Protecta, Protecta XT, Secura, Virtuoso and Virtuoso IIMedtronic, Inc.
Mounds View, MN
55112
Implementation of a manufacturing operations consolidation and equipment change at an approved component supplier.
P980022/S106
12/28/11
MiniMed Continuous Glucose Monitoring System, Guardian Real-Time System and Paradigm REAL-Time SystemMedtronic MiniMed
Northridge, CA
91325
Change in manufacturing location from Thailand to Moorpark, CA for CTS Electronics Manufacturing Solutions, Inc. (CTS), the supplier of the printed circuit board assemblies (PCBA), for the Paradigm REAL-Time Insulin pumps (models MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K), which are components of the device.
P980035/S250
12/13/11
Adapta, Advisa, EnRhythm, Relia, Sensia and VersaMedtronic, Inc.
Mounds View, MN
55112
Updated version of software which supports the Hybrid Slant Handler used for testing of hybrid subassemblies.
P980035/S254
12/23/11
Advisa ICDsMedtronic, Inc.
Mounds View, MN
55112
Updates to the test software packages.
P980049/S067
12/12/11
Paradym VR and DRSorin Group USA, Inc.
Plymouth, MN
55441
Alternate equipment for the laser welding process.
P980050/S069
12/19/11
Transvene CS SVC LeadMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P990034/S026
12/7/11
SynchroMed Refill Kit and Catheter Access Port KitMedtronic Neuromodulation
Minneapolis, MN
55432
Updating of the sterilant ethylene oxide residual parameter.
P990056/S015
12/21/11
Elecsys Total PSA ImmunoassayRoche Diagnostics
Indianapolis, IN
46250
Change to the intermediate storage form coating process of the Elecsys coated microparticles (beads).
P000007/S027
12/12/11
Edwards Porcine Stentless Bioprosthetic ValveEdwards Lifesciences, LLC
Irvine, CA
92614
New cleaning method for mold inserts.
P000021/S021
12/15/11
Dimension Vista TPSA FLEX Reagent CartridgeSiemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Change in supplier for Dextran T500 used in production of FLEX reagent cartridges.
P000027/S013
12/21/11
Elecsys Free PSA ImmunoassayRoche Diagnostics
Indianapolis, IN
46250
Change to the intermediate storage form coating process of the Elecsys coated microparticles (beads).
P000046/S020
12/21/11
STAARVISC II, Optivisc, Anikavisc Sodium HyaluronateAnika Therapeutics, Inc.
Bedford, MA
01730
Addition of two stability chambers.
P010012/S273
12/23/11
EASYTRAK 2 LV-1 and IS-1, EASYTRAK 3 LV-1, EASYTRAK 3 IS-1 and EASYTRAK Suture SleeveBoston Scientific CRM
St. Paul, MN
55112
Addition of an alternate second source supplier for accessories to implantable leads.
P010015/S146
12/13/11
Consulta and SyncraMedtronic, Inc.
Mounds View, MN
55112
Updated version of software which supports the Hybrid Slant Handler used for testing of hybrid subassemblies.
P010015/S149
12/23/11
Consulta and Syncra CRT-PsMedtronic, Inc.
Mounds View, MN
55112
Updates to the test software packages.
P010015/S150
12/19/11
AttainMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P010031/S281
12/13/11
Concerto II, Consulta, Maximo II, Protecta and Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Updated version of software which supports the Hybrid Slant Handler used for testing of hybrid subassemblies.
P010031/S283
12/14/11
 
Protecta and Protecta XT Families of CRT-DsMedtronic, Inc.
Mounds View, MN
55112
Multiple test method updates to a radiofrequency test application.
P010031/S285
12/23/11
Concerto, Concerto II, Consulta, Maximo II, Protecta and Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Implementation of a manufacturing operations consolidation and equipment change at an approved component supplier.
P010041/S028
12/12/11
Edwards Prima Plus Porcine Stentless Bioprosthetic ValveEdwards Lifesciences, LLC
Irvine, CA
92614
New cleaning method for mold inserts.
P020004/S067
12/21/11
Gore Excluder AAA EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86003
Addition of an alternate deployment fiber in the manufacturing process.
P020009/S080
12/5/11
Express 2 Monorail and Over-the-Wire Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P020025/S032
12/5/11
Blazer II XP Cardiac Ablation Catheter & Cable/ Blazer Prime XP Cardiac Ablation Catheter & CableBoston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P020027/S016
12/15/11
Dimension Vista FPSA FLEX Reagent CartridgeSiemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Change in supplier for Dextran T500 used in production of FLEX reagent cartridges.
P020052/S009
12/20/11
Response CV Cardioversion Electrophysiology Catheter with LumenSt. Jude Medical
Minnetonka, MN
55345
User of an additional sterilization chamber.
P030005/S080
12/5/11
CONTAK RENEWAL TR Family of CRT-PsBoston Scientific CRV
St. Paul, MN
55112
Addition of multiple pieces of manufacturing equipment already in use on other product lines.
P030025/S094
12/5/11
TAXUS Express 2 Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P030031/S037
12/23/11
EZ Steer ThermoCool Carto 3 Catheter, EZ Steer ThermoCool Nav TC Catheter, EZ Steer ThermoCool Non-Nav TC Catheter, EZ Steer ThermoCool Non-Nav THR CatheterBiosense Webster, Inc.
Diamond Bar, CA
91765
Additional rework process.
P030035/S091
12/30/11
Family of CRT-P DevicesSt. Jude Medical, Inc.
Sylmar, CA
91342
Alternate supplier for the thin film resistor component.
P030036/S038
12/19/11
SelectSecureMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P030054/S207
12/1/11
Unify CRTSt. Jude Medical
Sylmar, CA
91342
Addition of an alternate supplier.
P030054/S209
12/30/11
Family of CRT-D DevicesSt. Jude Medical, Inc.
Sylmar, CA
91342
Alternate supplier for the thin film resistor component.
P040012/S043
12/13/11
RX Acculink Cartoid Stent SystemAbbott Vascular, Inc. Temecula, CA
92591
Change in irradiation equipment.
P040016/S082
12/5/11
VeriFLEX (Liberté) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P040036/S028
12/23/11
EZ Steer ThermoCool Carto 3 Catheter, EZ Steer ThermoCool Nav TC Catheter, EZ Steer ThermoCool Non-Nav TC Catheter, EZ Steer
ThermoCool Non-Nav THR Catheter
Biosense Webster, Inc.
Diamond Bar, CA
91765
Additional rework process.
P040044/S041
12/19/11
Mynx Vascular Closure Device Product FamilyAccess Closure, Inc.
Mountain View, CA
94043
Minor modifications to the Hydrogel freeze-drying cycle process.
P040045/S028
12/2/11
Vistakon (senofilcon A) Brand Contact LensesJohnson &Johnson Vision Care, Inc. Jacksonville, FL
32256
Change in finished goods parameter testing.
P040045/S030
12/15/11
Vistakon
(senofilcon A) Brand Contact Lenses
Johnson &Johnson Vision Care, Inc. Jacksonville, FL
32256
Change to the sensors.
 
P050018/S016
12/20/11
AngioSculpt PTCA Scoring Balloon CatheterAngioscore, Inc.
Fremont, CA
94538
Addition of a second sterilization cycle, and of new equipment for the pouch peel strength process.
P050042/S014
12/1/11
ARCHITECT Anti-HCVAbbott Laboratories
Abbott Park, IL
60064
Modification to the bioburden test.
P060006/S022
12/5/11
Express SD Monorail Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P060006/S023
12/13/11
Express RD Monorail Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the heat shrink processing aid used to deliver heat shrink force for the proximal bond of the catheter.
P060008/S082
12/5/11
TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P060025/S008
12/13/11
3f Aortic BioprosthesisMedtronic ATS Medical, Inc.
Lake Forest, CA
92630
Addition of an alternate supplier for fresh equine pericardial tissue.
P060027/S034
12/12/11
Paradym CRTSorin Group USA, Inc.
Plymouth, MN
55441
Alternate equipment for the laser welding process.
P060035/S012
12/1/11
ARCHITECT CORE-MAbbott Laboratories
Abbott Park, IL
60064
Modification to the bioburden test.
P060037/S015
12/23/11
NexGen Complete Knee SolutionZimmer, Inc.
Warsaw, IN
46581
Changes to the device cleaning operations.
P060039/S032
12/19/11
Attain StarFixMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P070009/S014
12/2/11
REALIZE Adjustable Gastric Bands with Injection Port and ApplierEthicon Endo-Surgery, Inc.
Cincinnati, OH
45242
Change in the packaging process.
P080006/S037
12/19/11
Attain Ability, Attain ability Plus, Attain Ability StraightMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P080007/S010
12/7/11
Bard E-LUMINEXX Vascular StentBard Peripheral Vascular, Inc.
Tempe, AZ
85281
The surface treatment of the stent to be performed at an alternate supplier and the addition of several optimizations to the process flow.
P080023/S010
12/1/11
ARCHITECT COREAbbott Laboratories
Abbott Park, IL
60064
Modification to the bioburden test.
P080025/S023
12/28/11
InterStim® IIMedtronic Neuromodulation
Minneapolis, MN
55432
Upgrade and use version 6.4 of the Hybrid Slant Handler Software at Medtronic’s hybrid supplier.
P090007/S006
12/14/11
Elecsys® Anti-HCV Immunoassay and Elecsys® Preci- Control Anti-HCV on cobas e 411Roche Diagnostics
Indianapolis, IN
46250
Change to scalable lot sizes in the component manufacturing process of Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV and a change in the lyophilisation process.
P090008/S007
12/14/11
Elecsys® Anti-HCV Immunoassay and Elecsys® Preci- Control Anti-HCV on cobas e 601Roche Diagnostics
Indianapolis, IN
46250
Change to scalable lot sizes in the component manufacturing process of Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV and a change in the lyophilisation process.
P090009/S006
12/14/11
Elecsys® Anti-HCV Immunoassay and Elecsys® Preci- Control Anti-HCV on MODULAR ANALYTICS E170Roche Diagnostics
Indianapolis, IN
46250
Change to scalable lot sizes in the component manufacturing process of Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV and a change in the lyophilisation process.
P090013/S045
12/13/11
Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Updated version of software which supports the Hybrid Slant Handler used for testing of hybrid subassemblies.
P090013/S048
12/19/11
CapSureFix MRIMedtronic, Inc.
Mounds View, MN
55112
Addition of a new Vision System Equipment Controller (EC) Fixture system as part of the Sterile Pack process.
P090018/S017
12/14/11
EsteemEnvoy Medical Corporation
St. Paul, MN
55110
Change to the final shelf box packaging process for the Esteem implantable components.
P100023/S027
12/5/11
ION Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility.
P100023/S028
12/7/11
Ion Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Addition of an in-house process for cutting tubing material.
P100023/S029
12/14/11
Ion Platinum Chromium Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Update to the port weld heat shrink removal process.
P110001/S002
12/19/11
RX Herculink Elite Renal and Biliary Stent SystemAbbott Vascular
Temecula, CA
92592
Addition of an automated in-process verification system.
P110010/S002
12/14/11
Promus Element Plus Platinum Chromium Everolimus-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Update to the port weld heat shrink removal process.
P110011/S001
12/7/11
Assurant Cobalt Iliac Balloon Expandable Stent SystemMedtronic Vascular Santa Rosa, CA
95403
Change to the product print information from a manual process to an automated process.
P110019/S004
12/7/11
XIENCE PRIME and PRIME LL Everolimus-Eluting Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA
92591
Reduction in frequency monitoring of the stent site temperature.
P110019/S005
12/30/11
XIENCE PRIME Everolimus-Eluting Coronary Stent SystemAbbott Vascular, Inc.
Temecula, CA
92591
Automation of the existing balloon necking process, leaving the current manual process as an alternate.

Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 83

Summary of PMA Originals Under Review
Total Under Review: 85
Total Active: 34
Total On Hold: 51
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 555
Total Active: 417
Total On Hold: 138
Number Greater Than 180 Days: 8

Summary of All PMA Submissions Received
Originals: 5
Supplements: 56

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 83
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 155.9
FDA Time: 120.7 Days MFR Time: 35.2 Days