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 APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P100046 12/14/11 | AtriCure Synergy Ablation System | Boston 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 IgM | Roche 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 APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P820003/S114 12/21/11 Real-Time | External Pulse Generators | Medtronic, 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 AFP | Abbott 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 Wear | Cooper 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 Kit | Medtronic 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 Pump | Medtronic, 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 System | 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. |
| P890003/S238 12/6/11 Real-Time | CareLink Remote Home Monitor/ CardioSight Reader/CareLink Express Monitor | 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. |
| P890003/S242 12/21/11 Real-Time | CareLink Programmer | Medtronic, 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 Models | Medtronic, 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 System | Spectranetics, 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 PSA | Abbott 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 PSA | Abbott 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 Leads | Biotronik, 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 AspireHC | Cyberonics 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 BPH | Urologix, 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-HCV | Abbott 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 System | Cochlear 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 System | Cochlear 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 PSA | Abbott 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 PSA | Abbott 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/ Protecta | 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. |
| 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 System | Medtronic, 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 System | Medtronic, 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/EnRhythm | 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. |
| P990071/S009 12/21/11 180-Day | ThermoCool SF Catheters | Biosense 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 Catheters | Biosense 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) System | Allergan, 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, v2.0 | Roche 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 v2.0 | Roche 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 Systems | MED-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 Device | Medtronic 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 System | Hologic, 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-P | 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. |
| 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 Sealant | NeoMend, 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 System | Cook, 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 System | Cordis 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 | Orthovisc | Anika Therapeutics, Inc. Bedford, MA 01730 | Approval for a manufacturing site located in Bedford, Massachusetts. |
| P030023/S001 12/14/11 180-Day | Ophtec Capsular Tension Ring | Ophtec 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 Catheters | Biosense 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 Catheters | Biosense 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 Catheter | Biosense 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 Aesthetic | Sanofi-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 System | Endologix, 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 | ExAblate | InSightec, 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 Matrix | Luitpold 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 Valves | St. 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 Valves | St. 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 System | DePuy 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 System | Confluent 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 Catheters | Biosense 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 Catheters | Biosense 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 Catheter | Biosense 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 Endoprosthesis | W.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 v2.0 | Roche 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-HCV | Abbott 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 Confirmatory | Abbott 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 AUSAB | Abbott 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 AUSAB | Abbott 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 Assays | Abbott 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 2.0 | Abbott 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 2.0 | Abbott 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 v2.0 | Roche 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-M | Abbott 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 Knee | Zimmer, 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 Valve | Sorin 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 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. |
| P070001/S010 12/22/11 135-Day | ProDisc-C Total Disc Replacement | Synthes 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 Leads | Biotronik, 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 System | Cook, 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 Wear | Cooper 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 Automation | Hologic, 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 CORE | Abbott 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 MRI | 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. |
| P090022/S007 12/20/11 135-Day | Softec HD, Softec I and Softec HD PS Intraocular Lenses | Lenstec, Inc, St. Petersburg, FL 33716 | Approval of a new lens analyzer. |
| P100020/S001 12/29/11 180-Day | COBAS HPV Test | Roche 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 System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval of the post-approval study protocol. |
| P100028/S001 12/5/11 180-Day | Formula Balloon- Expandable Renal Stent | Cook Medical, Inc. Bloomington, IN 47402 | Approval of the post-approval study protocol. |
| P100029/S003 12/22/11 180-Day | Trifecta Heart Valves | St. 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 APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N12159/S029 12/21/11 | Surgicel Absorbable Hemostats | Ethicon, 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 | CapSure | Medtronic, 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 Stimulation | 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. |
| 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 Novus | Medtronic, 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 System | 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. |
| P860004/S164 12/7/11 | SynchroMed Refill Kit and Catheter Access Port Kit | Medtronic Neuromodulation Minneapolis, MN 55432 | Updating of the sterilant ethylene oxide residual parameter. |
| P860004/S166 12/28/11 | SynchroMed II | Medtronic 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 Valve | Edwards Lifesciences, LLC Irvine, CA 92614 | New cleaning method for mold inserts. |
| P870056/S044 12/12/11 | Carpentier-Edwards Porcine Bioprosthetic Valve | Edwards Lifesciences, LLC Irvine, CA 92614 | New cleaning method for mold inserts. |
| P870077/S040 12/12/11 | Carpentier-Edwards Duraflex Low Pressure Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 | New cleaning method for mold inserts. |
| P880047/S018 12/14/11 | Gynecare Interceed Absorbable Adhesion Barrier | Ethicon, Inc. Somerville, MN 08876 | Addition of new equipment. |
| P880086/S213 12/30/11 | Family of Pacemaker Devices | St. Jude Medical, Inc. Sylmar, CA 91342 | Alternate supplier for the thin film resistor component. |
| P890003/S239 12/7/11 | CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 | Manufacturing changes to accommodate an equivalent part addition. |
| P890003/S241 12/19/11 | CapSure | Medtronic, 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 Torquer | Boston 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 System | Boston 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 Catheters | Spectranetics Corporation Colorado Springs, CO 80921 | Change in EO sterilization process monitoring. |
| P910023/S280 12/1/11 | Fortify ICD | St. Jude Medical Sylmar, CA 91342 | Addition of an alternate supplier. |
| P910023/S282 12/30/11 | Family of ICD Devices | St. Jude Medical, Inc. Sylmar, CA 91342 | Alternate supplier for the thin film resistor component. |
| P920015/S085 12/19/11 | Sprint Quattor, Subcutaneous Lead | Medtronic, 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 Endoprosthesis | American 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/ Cable | Boston 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 System | Medtronic, Inc. Mounds View, MN 55112 | Implementation of the new electrical test systems. |
| P930039/S065 12/19/11 | CapSure, SureFix | Medtronic, 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 Kit | Boston 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 Balloon | Boston 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 Lead | Medtronic, 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 External | Medtronic 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 Catheters | St. Jude Medical Minnetonka, MN 55345 | User of an additional sterilization chamber. |
| P960042/S033 12/27/11 | Spectranetics Laser Sheaths | Spectranetics Corporation Colorado Springs, CO 80921 | Change in EO sterilization process monitoring. |
| D970003/S133 12/5/11 | INSIGNIA and ALTRUA Families of Pacemakers | Boston 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® Wand | Cyberonics, 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® System | Cyberonics, 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® II | Medtronic 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 System | CryoLife, Inc. Cardiogenesis Kennesaw, GA 30144 | Changes to the manufacturing of the handpiece delivery system. |
| P970055/S012 12/29/11 | Parvovirus B19 IgM Enzyme Immunoassay | Biotrin 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 Cable | Boston 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 II | Medtronic, 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 ICDs | Medtronic, 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 II | Medtronic, 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 System | Medtronic 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 Versa | Medtronic, 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 ICDs | Medtronic, Inc. Mounds View, MN 55112 | Updates to the test software packages. |
| P980049/S067 12/12/11 | Paradym VR and DR | Sorin Group USA, Inc. Plymouth, MN 55441 | Alternate equipment for the laser welding process. |
| P980050/S069 12/19/11 | Transvene CS SVC Lead | Medtronic, 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 Kit | Medtronic Neuromodulation Minneapolis, MN 55432 | Updating of the sterilant ethylene oxide residual parameter. |
| P990056/S015 12/21/11 | Elecsys Total PSA Immunoassay | Roche 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 Valve | Edwards Lifesciences, LLC Irvine, CA 92614 | New cleaning method for mold inserts. |
| P000021/S021 12/15/11 | Dimension Vista TPSA FLEX Reagent Cartridge | Siemens 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 Immunoassay | Roche 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 Hyaluronate | Anika 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 Sleeve | Boston 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 Syncra | Medtronic, 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-Ps | Medtronic, Inc. Mounds View, MN 55112 | Updates to the test software packages. |
| P010015/S150 12/19/11 | Attain | Medtronic, 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 XT | Medtronic, 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-Ds | Medtronic, 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 XT | Medtronic, 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 Valve | Edwards Lifesciences, LLC Irvine, CA 92614 | New cleaning method for mold inserts. |
| P020004/S067 12/21/11 | Gore Excluder AAA Endoprosthesis | W.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 System | Boston 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 & Cable | Boston 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 Cartridge | Siemens 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 Lumen | St. Jude Medical Minnetonka, MN 55345 | User of an additional sterilization chamber. |
| P030005/S080 12/5/11 | CONTAK RENEWAL TR Family of CRT-Ps | Boston 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 System | Boston 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 Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 | Additional rework process. |
| P030035/S091 12/30/11 | Family of CRT-P Devices | St. Jude Medical, Inc. Sylmar, CA 91342 | Alternate supplier for the thin film resistor component. |
| P030036/S038 12/19/11 | SelectSecure | Medtronic, 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 CRT | St. Jude Medical Sylmar, CA 91342 | Addition of an alternate supplier. |
| P030054/S209 12/30/11 | Family of CRT-D Devices | St. Jude Medical, Inc. Sylmar, CA 91342 | Alternate supplier for the thin film resistor component. |
| P040012/S043 12/13/11 | RX Acculink Cartoid Stent System | Abbott Vascular, Inc. Temecula, CA 92591 | Change in irradiation equipment. |
| P040016/S082 12/5/11 | VeriFLEX (Liberté) 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. |
| 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 Family | Access 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 Lenses | Johnson &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 Catheter | Angioscore, 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-HCV | Abbott Laboratories Abbott Park, IL 60064 | Modification to the bioburden test. |
| P060006/S022 12/5/11 | Express SD Monorail Premounted Stent System | Boston 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 System | Boston 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 System | Boston 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 Bioprosthesis | Medtronic ATS Medical, Inc. Lake Forest, CA 92630 | Addition of an alternate supplier for fresh equine pericardial tissue. |
| P060027/S034 12/12/11 | Paradym CRT | Sorin Group USA, Inc. Plymouth, MN 55441 | Alternate equipment for the laser welding process. |
| P060035/S012 12/1/11 | ARCHITECT CORE-M | Abbott Laboratories Abbott Park, IL 60064 | Modification to the bioburden test. |
| P060037/S015 12/23/11 | NexGen Complete Knee Solution | Zimmer, Inc. Warsaw, IN 46581 | Changes to the device cleaning operations. |
| P060039/S032 12/19/11 | Attain StarFix | Medtronic, 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 Applier | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 | Change in the packaging process. |
| P080006/S037 12/19/11 | Attain Ability, Attain ability Plus, Attain Ability Straight | Medtronic, 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 Stent | Bard 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 CORE | Abbott Laboratories Abbott Park, IL 60064 | Modification to the bioburden test. |
| P080025/S023 12/28/11 | InterStim® II | Medtronic 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 411 | Roche 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 601 | Roche 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 E170 | Roche 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 MRI | Medtronic, 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 MRI | Medtronic, 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 | Esteem | Envoy 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 System | Boston 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 System | Boston 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 System | Boston 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 System | Abbott 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 System | Boston 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 System | Medtronic 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 Systems | Abbott 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 System | Abbott 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
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