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Medical Devices
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February 2009 PMA Approvals
Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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. Information about the PDF Reader is available.
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P070014 2/13/09 |
LifeStent FlexStar and FlexStar XL Vascular Stent System | Bard Peripheral Vascular, Inc. Tempe AZ 85280 |
Approval for the LifeStent FlexStar and FlexStar XL Vascular Stent System. The device is indicated for improvement of luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 160 mm in length in the native superficial femoral artery (SFA) and proximal popliteal artery with reference vessel diameters ranging from 4.00 – 6.5 mm. |
| P080021 2/2/09 |
XACT® Foldable Hydrophobic Acrylic Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens (IOL) | Advanced Vision Science, Inc. Goleta, CA 93117 |
Approval for the XACT® Foldable Hydrophobic Acrylic Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens (IOL). Model X-60 and Model X-70. This device is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P840064/S038 2/27/09 135-Day |
VISCOAT®, DUOVISC® and DISCOVISC® | Alcon Research, Ltd. Fort Worth , TX 76134 |
Approval for the addition of a second line-perform labeling and assembly of ophthalmic viscosurgical devices (OVD). |
| P860004/S102 2/6/09 Special |
SynchroMed Infusion System | Medtronic Neuromodulation Minneapolis , MN 55432 |
Approval for a new coagulopathies warning. |
| P860057/S054 2/20/09 Real-Time |
Carpentier-Edwards Perimount Magna® Ease Mitral Bioprostheses | Edwards Lifesciences, LLC Irvine , CA 92614 |
Approval for minor modifications to the 3.8 oz jar packaging system used for the models 7000 and 7000TFX, Carpentier-Edwards Perimount Magna® mitral bioprostheses and a new name and model number. The device, as modified, will be marketed under the trade name Carpentier-Edwards Perimount Magna® Ease Mitral Bioprostheses models 7100 and 7100TFX and are indicated for mitral valve replacement. |
| P880031/S016 2/18/09 Real-Time |
Healon D® | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Approval to change the pH product specification range for Healon D® from 7.1 – 7.5 to 6.8 – 7.6. |
| P890003/S155 2/24/09 Real-Time |
Model 2090 Medtronic Carelink® Programmer Radio Frequency Transceiver (RFT) | Medtronic, Inc. Mounds View, MN 55112 | Approval for the Model 2090 Medtronic Carelink® Programmer Radio Frequency Transceiver (RFT). |
| P890047/S026 2/27/09 135-Day |
PROVISC® Ophthalmic Viscosurgical Device | Alcon Research, Ltd. Fort Worth , TX 76134 |
Approval for the addition of a second line-perform labeling and assembly of ophthalmic viscosurgical devices (OVD). |
| P900022/S012 2/4/09 Real-Time |
Reply Pacer Embedded software W1.5.1 and Associated Programmer Application Software Version Smartview 2.10 UG1 | ELA Medical, Inc. Plymouth , MN 55441 | Approval for the Reply pacer embedded software W1.5.1 and associated programmer application software version Smartview 2.10 UG1. |
| P900056/S095 2/17/09 135-Day |
Rotablator™ Rotational Angioplasty System – RotaWire™ Guidewire | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for changes to the test method for the device. |
| P900066/S008 2/19/09 135-Day |
ISPAN Perfluoropropane C3F8 Gas | Air Liquide Healthcare America Corporation Plumsteadville , PA 18949 | Approval for change of Perfluoropropane Gas supplier. |
| P910023/S199 2/4/09 Real-Time |
Cadence Family of ICDs |
St. Jude Medical Cardiac Rhythm Management Division 94086 |
Approval for the Current+ ICDs and Promote+ CRT-Ds. |
| P930014/S024 2/5/09 Real-Time |
AcrySert™ Delivery System with the AcrySof® IQ IOL Model SN60WS | Alcon Research, Ltd. Fort Worth , TX 76134 |
Approval for the AcrySert™ Delivery System with the AcrySof® IQ IOL Model SN60WS. |
| P930014/S029 2/5/09 Real-Time |
AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT3, SN6AT4 and SN6AT5 | Alcon Research, Ltd. Fort Worth , TX 76134 |
Approval for IOL models SN6AT3, SN6AT4 and SN6AT5. The device, as modified, will be marketed under the trade name Acrysof ® IQ Toric Intraocular Lenses and is indicated for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision. |
| P940015/S012 2/26/09 Panel |
Synvisc-One | Genzyme Biosurgery Cambridge , MA 02142 | Approval for the Synvisc-One. The device is indicated for the treatment of pain in osteoarthritis of the knee in patients who have filed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. |
| P950022/S058 2/27/09 180-Day |
Riata ST Optim and Durata Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, LLC in Arecibo, Puerto Rico. |
| P950029/S039 2/4/09 Real-Time |
Reply Pacer Embedded software W1.5.1 and Associated Programmer Application Software Version Smartview 2.10 UG1 | ELA Medical, Inc. Plymouth , MN 55441 | Approval for the Reply pacer embedded software W1.5.1 and associated programmer application software version Smartview 2.10 UG1. |
| P970021/S025 2/11/09 Real-Time |
Gynecare Thermachoice III Uterine Balloon Therapy (UBT) System | Ethicon, Inc. Somerville , NJ 08876 | Approval for a modified Tri-Y, component of the balloon catheter, and a change to the raw material specification for the pressure tubing. |
| D980003/S007 2/13/09 180-Day | Keramos™ Ceramic/Ceramic Total Hip System | Encore Medical, L.P. Austin , TX 78758 |
Approval for the use of polyethylene replacement acetabular liners. |
| P980016/S173 2/13/09 Real-Time |
EnTrust® DR/VR Implantable Cardioverter Defibrillators | Medtronic, Inc. Mounds View, MN 55112 | Approval for an update to the approved Lead Integrity Alert (LIA) software application model SW01 which corrects an unintended interaction between the EnTrust DR/VR ICDs and LIA. |
| P980035/S114 2/4/09 135-Day |
Adepta, Sensia, and Versa IPGs | Medtronic, Inc. Mounds View, MN 55112 | Approval to change the production test limits for the sin2 sense detect threshold in the non-pacing mode. |
| P9800049/S041 2/3/09 Real-Time |
IGBT with the part number 10N170 | ELA Medical, Inc. Plymouth , MN 55441 | Approval for the IGBT (Part number 10N170) to be used in the Shock 6 hybrid module T273 (SCOT273) for the Ovatio ICD and CRT devices. |
| P980049/S044 2/4/09 Real-Time |
Reply Pacer Embedded software W1.5.1 and Associated Programmer Application Software Version Smartview 2.10 UG1 | ELA Medical, Inc. Plymouth , MN 55441 | Approval for the Reply pacer embedded software W1.5.1 and associated programmer application software version Smartview 2.10 UG1. |
| P990034/S012 2/6/09 Special |
IsoMed Infusion System | Medtronic Neuromodulation Minneapolis , MN 55432 | Approval for a new coagulopathies warning. |
| P000054/S020 2/20/09 Real-Time |
INFUSE™ Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis , TN 38132 |
Approval for changes in the exterior cartons used to ship one or more units of INFUSE Bone Graft. |
| P000058/S031 2/20/09 Real-Time |
InFuse™ Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis , TN 38132 |
Approval for changes in the exterior cartons used to ship one or more units of InFuse Bone Graft. |
| P010013/S020 2/6/09 180-Day |
NovaSure® Impedance Controlled Endometrial Ablation System | Hologic, Inc. Bedford , MA 01730 | Approval for a manufacturing site located at Hologic Corporation, El Coyol Alajuela, Costa Rica. |
| P010013/S021 2/4/09 Real-Time |
NovaSure® Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough , MA 01752 |
Approval for the Navistar ThermoCool Catheter and EZ Steer ThermoCool Catheter-Nav version. These devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording), and when used with the Stockert 70 generator, for the treatment of: 2) Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (MI) in adults. 3) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. |
| P010050/S007 2/9/09 180-Day |
Immulite®/ Immulite® 2000 HBsAg | Siemens Healthcare Diagnostics Los Angeles , CA 90045 |
Approval for replacement of the sodium based buffer with potassium phosphate buffer and addition of 2.0% normal mouse serum and 1.2% e-amino-n-caproic acid in Reagent A, and the addition of 0.2% sodium heparin in Reagent B followed by refiltering of diluent, and is indicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis B virus infections in conjunction with other serological and clinical information. |
| P020004/S041 2/26/09 Real-Time |
Excluder AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86002 |
Approval for a change to the material and specification of the delivery system deployment line. |
| P020018/S031 2/24/09 Special |
Zenith® Flex Endovascular Graft | Cook Inc. Bloomington , IN 47402 | Approval for modifying the product labeling to clarify removal of the trigger wire. |
| P030017/S069 2/20/09 135-Day |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Corporation Sylmar , CA 91342 |
Approval for a modification to the Implantable Pulse Generator (IPG) test procedure to include the addition of a new piece of equipment. |
| P030017/S074 2/25/09 135-Day |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Corporation Sylmar , CA 91342 |
Approval for modifications to the IPG assembly process. |
| P030022/S008 2/18/09 180-Day |
Reflection® Ceramic Acetabular System – Line Addition | Smith & Nephew, Inc. Alexandria , CA 22314 |
Approval for 1) The addition of the Reflection 3 (R3) Ceramic (Biolox forte) Liners (32mm ID, 36mm ID), which feature a factory-assembled titanium alloy outer ring; the modified acetabular shell (i.e., R3 Acetabular Shells) to accept the modified ceramic liners; and the 36mm Biolox forte femoral head (+0, +4. +8); 2) An additional manufacturing site at Smith & Nephew Orthopaedics, Tuttlingen, Germany, for the manufacturing and assembly of the titanium ring; and 3) A sterilization site for the R3 ceramic liners with the affixed outer metal ring at BBF Sterilization Services, GmbH, Kernen, Germany. |
| P030031/S010 2/20/09 180-Day |
NaviStar RMT ThermoCool Diagnostic/Ablation Deflectable Tip Catheters | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for modifications to the tip assembly. |
| P030031/S011 2/6/09 Panel |
Navistar ThermoCool Catheter and EZ Steer ThermoCool Catheter-Nav | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for the Navistar ThermoCool Catheter and EZ Steer ThermoCool Catheter-Nav version. These devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording), and when used with the Stockert 70 generator, for the treatment of 1) Type I atrial flutter in patients age 18 or older. 2) Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (MI) in adults. 3) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. |
| P030036/S009 2/25/09 135-Day |
SelectSecure™ Lead Model 3830 | Medtronic, Inc. Mounds View, MN 55112 | Approval for the following changes: 1) a change in the manufacturing facility for the drug vial filling process; 2) the addition of a contract laboratory for drug release testing; and 3) a change in a quality control test used to determine a specific attribute of an incoming raw material. |
| P030054/S113 2/4/09 Real-Time |
Epic HF/Atlas+ Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the Current+ ICDs and Promote+ CRT-Ds. |
| P030054/S116 2/27/09 180-Day |
Atlas II + HF and Promote CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, LLC in Arecibo, Puerto Rico. |
| P040002/S023 2/20/09 Real-Time |
34mm Accessories and IntuiTrak Delivery System | Endologix, Inc. Irvine , CA 92618 |
Approval to move the 34mm accessories over to IntuiTrak delivery system line as well as making a stand alone version of the 34mm bifurcated body delivery sheath available. |
| P040028/S003 2/27/09 180-Day |
LUMA™ Cervical Imaging System | SpectraScience, Inc. San Diego , CA 92121 |
Approval for a manufacturing site located at SpectraScience, Inc. in San Diego, California. |
| P040033/S010 2/13/09 Real-Time |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Memphis , TN 38116 | Approval for the addition of surgical instruments for use with the BHR System and revisions to the surgical technique. |
| P040036/S007 2/5/09 180-Day | NaviStar ThermoCool Deflectable Diagnostic Ablation Catheter | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval of the post-approval study protocol. |
| P040036/S008 2/20/09 180-Day |
NaviStar RMT ThermoCool Diagnostic Ablation Deflectable Tip Catheters | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for modifications to the tip assembly. |
| P040038/S014 2/23/09 135-Day |
Xact Carotid Stent Systems | Abbott Vascular, Inc. Santa Clara , CA 95054 |
Approval for the addition of a new receiving inspection parameter. |
| P040040/S006 2/4/09 180-Day |
AMPLATZER Muscular VSD Occluder | AGA Medical Plymouth , MN 55442 |
Approval of the post-approval study protocol. |
| P050012/S016 2/13/09 180-Day |
DexCom SEVEN System | DexCom, Inc. San Diego , CA 92121 |
Approval for modifications to the Receiver user interface and algorithm, and modifications to the Transmitter to make it compatible to the modified Receiver algorithm. |
| P050017/S002 2/3/09 180-Day |
Zilver Vascular Stent | Cook Inc. Bloomington , IN 47402 | Approval for a manufacturing site located at Cook Ireland, Ltd., Limerick, Ireland for manufacturing and final manufacturing to include labeling and packaging, and for a sterilization site located at Isotron Ireland, Ltd., Tullamore, Ireland. |
| P050017/S003 2/3/09 180-Day |
Zilver Vascular Stent | Cook Inc. Bloomington , IN 47402 | Approval for a manufacturing site located at Cook Ireland, Ltd., Limerick, Ireland for manufacturing and final manufacturing to include labeling and packaging, and for a sterilization site located at Isotron Ireland, Ltd., Tullamore, Ireland. |
| P050037/S017 2/3/09 Real-Time |
Radiesse, 1.3 cc and 0.3 cc | BioForm Medical, Inc. Franksville , WI 53126 |
Approval for: 1. Changing the fill volume from a maximum deliverable fill volume of 1.3 cc to a maximum deliverable fill volume of 1.5 cc. 2. Changing the syringe barrel handle from a molded straight handle to a molded handle with an ergonomic curved handle. 3. Modification to the Instruction for Use to include the 1.5 cc fill volume in the Device Description section of the Instructions for Use. 4. Creation of package labeling specific to the 1.5 cc fill volume, identical to the package labeling for the 0.3 cc and 1.3 cc fill volume products with the exception of the identified fill volume and part number. |
| P050037/S018 2/25/09 Real-Time |
Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville , WI 53126 |
Approval for the addition of a 0.8 cc fill volume injectable implant and associated labeling changes. |
| P050052/S018 2/3/09 Real-Time |
Radiesse, 1.3 cc and 0.3 cc | BioForm Medical, Inc. Franksville , WI 53126 |
Approval for: 1. Changing the fill volume from a maximum deliverable fill volume of 1.3 cc to a maximum deliverable fill volume of 1.5 cc. 2. Changing the syringe barrel handle from a molded straight handle to a molded handle with an ergonomic curved handle. 3. Modification to the Instruction for Use to include the 1.5 cc fill volume in the Device Description section of the Instructions for Use. 4. Creation of package labeling specific to the 1.5 cc fill volume, identical to the package labeling for the 0.3 cc and 1.3 cc fill volume products with the exception of the identified fill volume and part number. |
| P050052/S020 2/25/09 Real-Time |
Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville , WI 53126 |
Approval for the addition of a 0.8 cc fill volume injectable implant and associated labeling changes. |
| P050053/S011 2/20/09 Real-Time |
InFuse® Bone Graft | Medtronic, Inc. Memphis , TN 38132 | Approval for changes in the exterior cartons used to ship one or more units of InFuse Bone Graft. |
| P060022/S002 2/18/09 Real-Time |
Akreos® Posterior Chamber Intraocular Lens | Bausch & Lomb Rochester , NY 14609 | Approval for changes to the packaging, labeling and design of the Akreos® Posterior Chamber Intraocular Lens, Model: Akreos Advanced Optics Aspheric Intraocular Lens, AO60. The device, as modified, will be marketed under the trade name Akreos AO Micro Incision Lens, Model MI60L and is indicated for the replacement of the human crystalline lens in the visual correction of aphakia. |
| P060027/S005 2/3/09 Real-Time |
IGBT with the part number 10N170 | ELA Medical, Inc. Plymouth , MN 55441 | Approval for the IGBT (Part number 10N170) to be used in the Shock 6 hybrid module T273 (SCOT273) for the Ovatio ICD and CRT devices. |
| P060027/S008 2/4/09 Real-Time |
Reply Pacer Embedded software W1.5.1 and Associated Programmer Application Software Version Smartview 2.10 UG1 | ELA Medical, Inc. Plymouth , MN 55441 | Approval for the Reply pacer embedded software W1.5.1 and associated programmer application software version Smartview 2.10 UG1. |
| P060031/S002 2/25/09 Special |
Bio-Rad MONOLISA™ Anti-HBc EIA | Bio-Rad Laboratories Redmond , WA 98052 | Approval for changes in the recommendation for specimen storage. |
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P060033/S014 2/17/09 |
Endeavor Zotarolimus-Eluting Coronary Stent System and Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa , CA 95403 |
Approval for an extension of the in-process shelf-life of the stent coating formulations. |
| P060034/S002 2/20/09 Real-Time |
Bio-Rad MONOLISA™ Anti-HBc IgM EIA | Bio-Rad Laboratories Redmond , WA 98052 | Approval for an amendment to the package insert with the addition of the statement that allows storage of the Working Conjugate Solution at room temperature for 30 hours, up to 10 cycles of 3 hours at room temperature allowed for the device. |
| P060037/S006 2/13/09 135-Day |
NexGen ™ LPS and LPS-Flex Mobile Bearing Knee System | Zimmer Spine Warsaw , IN 46581 |
Approval for an alternate manufacturing process for the LPS femoral components, an additional cleaning line, new grinding equipment, and an additional inspection step. |
| P060038/S002 2/27/09 Real-Time |
Mitroflow Aortic Pericardial Heart Valve Model LX | CarboMedics, Inc. Arvada , CO 80004 |
Approval for manufacturing process improvements to the Aortic Pericardial Heart Valve Model 12. The device, as modified, will be marketed unde the trade name Mitroflow Aortic Pericardial Heart Valve Model LX and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. |
| P060039/S002 2/2/09 180-Day |
Attain StarFix Model 4195 Lead | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 | Approval of the post-approval study protocol. |
| P070009/S004 2/23/09 135-Day |
REALIZE™ Adjustable Gastric Band | Ethicon Endo-Surgery, Inc. Cincinnati , OH 45242 |
Approval to modify the injection port torque inspection procedure by replacing pre-and post-torque test inspections with visual and functional inspections and modify three injection port manufacturing documents to incorporate the changes in the torque inspection procedure and to improve clarity of instructions. |
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 |
|---|---|---|---|
| P820003/S088 2/11/09 | Model 5441 EPG Plastic Cover | Medtronic, Inc. Mounds View, MN 55112 | Transferring of the final in-process inspection and final package process steps from Medtronic Rice Creek facility to the contract manufacturer. |
| P860019/S231 2/19/09 | Maverick™ OTW and Maverick2™ Monorail Percutaneous Coronary Angioplasty (PTCA) Catheter | Boston Scientific Corporation Cardiovascular Maple Grove , MN 55311 | Elimination of the Final Functional Audits for the devices. |
| P880091/S030 2/13/09 | Elastic®, Elastimide® Elastic Toric® and Aspheric Elastimide® Ultraviolet Absorbing Posterior Chamber Intraocular Lenses | STAAR Surgical Company Monrovia , CA 91016 |
Installation of a new collimator on the Autometronics OBV-750 optical bench. |
| P950022/S057 2/27/09 | Riata, Riata ST, and Durata Families of Leads | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sylmar , CA 91342 |
Addition of an alternate semi-automated packaging process. |
| P950029/S040 2/23/09 | Symphony SR 2250, Symphony DR 2550, Rhapsody SR 2210, Rhapsody DR 2510, Rhapsody DR 2530, Reply SR, and Reply DR Pacemakers | ELA Medical, Inc. Plymouth , MN 55441 | Change in the type of x-ray machine. |
| P960013/S042 2/27/09 | Tendril, Tendril ST and OptiSense Family of Leads | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sylmar , CA 91342 |
Addition of an alternate semi-automated packaging process. |
| P960030/S025 2/27/09 | Passive Plus, IsoFlex S, IsoFlex P, and IsoFlex Optim Family of Leads | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sylmar , CA 91342 |
Addition of an alternate semi-automated packaging process. |
| P960040/S187 2/13/09 | Confient, Frontier, and Vitality | Guidant Corporation St. Paul , MN 55112 |
New laser marking equipment to increase production capacity. |
| P970003/S105 2/23/09 | VNS Therapy and Pulse Duo | Cyberonics, Inc. Houston , TX 77058 |
Approval to add an additional automated electrical test to the manufacturing process. |
| D970003/S108 2/13/09 | Insignia, Altrua | Guidant Corporation St. Paul , MN 55112 |
New laser marking equipment to increase production capacity. |
| D970012/S059 2/13/09 | AMS 700 and AMBICOR Inflatable Penile Prosthesis | American Medical Systems Minnetonka , MN 55343 |
Change to an in-process packaging seal test for trays and pouches for the device. |
| P980016/S174 2/10/09 |
EnTrust, Virtuoso, Maximo II, Secura, Marquis, Maximo, Intrinsic 35J, and Virtuoso II ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the outlier criteria for the Open Circuit Voltage (OCV) test. |
| P980016/S176 2/25/09 | Virtuoso Family of Implantable Cardioverter Defibrillator (ICD) | Medtronic, Inc. Mounds View, MN 55112 | Change to the final device test used on multiple product families. |
| P980024/S003 2/10/09 | PathVysion™ HER-2 DNA Probe Kit | Abbott Molecular, Inc. Des Plaines , IL 60018 |
Change to scale up the production of cell paste used to prepare probes to reduce manufacturing time. |
| P980037/S028 2/24/09 | AngioJet® Rheolytic™ Thrombectomy System | MEDRAD Interventional/ Possis Minneapolis , MN 55433 |
Alternate process Challenge Device (PCD) biological indicator (BI) to monitor the ethylene oxide sterilization process. |
| P980037/S029 2/27/09 | AngioJet® Rheolytic™ Thrombectomy System | MEDRAD Interventional/ Possis Minneapolis , MN 55433 |
Modification to the allowable combinations of MEDRAD Interventional/ Possis (MIP) products that may be sterilized with an Ethylene Oxide (EO) sterilization cycle. |
| P980049/S045 2/23/09 | Ovatio VR 6250 and Ovatio DR 6550 ICDs | ELA Medical, Inc. Plymouth , MN 55441 | Change in the type of x-ray machine. |
| P990040/S007 2/6/09 | TRUFILL® n-Butyl Cyanoacrylate Liquid Embolic | Cordis Neurovascular, Inc. Miami Lakes , FL 33014 |
Changes and modifications as follows: 1) The transfer of the manufacturing of the TRUFILL n-BCA Liquid Embolic System from one building to another within the same facility; 2) A clarification of the Instructions for Use (1FU) The removal of a redundant incoming receiving inspection for the n-BCA and tantalum Pouch; 3) The removal of a specification for the n-BCA and tantalum pouch; and 4) Modification of the seal specifications for the n-BCA and tantalum pouch. |
| P990041/S010 2/25/09 | ETI-AB-EBK PLUS Kit | DiaSorin, Inc. Stillwater , MN 55082 | Approval to move the manufacturing of the recombinant HBeAg from a supplier to inside DiaSorin and to revise the QC procedure for purified r-HBe Ag raw material acceptance. |
| P990043/S011 2/25/09 | ETI-EBK PLUS Kit | DiaSorin, Inc. Stillwater , MN 55082 | Approval to move the manufacturing of the recombinant HBeAg from a supplier to inside DiaSorin and to revise the QC procedure for purified r-HBe Ag raw material acceptance. |
| P000053/S020 2/13/09 | AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka , MN 55343 | Change to an in-process packaging seal test for trays and pouches for the device. |
| P010012/S200 2/13/09 | Renewal, renewal RF, Renewal Zodiac, Frontier and Livian | Guidant Corporation St. Paul , MN 55112 | New laser marking equipment to increase production capacity. |
| P010020/S012 2/13/09 | Acticon Neosphincter Artificial Bowel Sphincter | American Medical Systems Minnetonka , MN 55343 | Change to an in-process packaging seal test for trays and pouches for the device. |
| P010031/S140 2/10/09 | Maximo II CRT-D, Concerto ICD, Consulta CRT-D, InSync III Marquis ICD, InSync III Protect ICD, InSync Sentry ICD, and Concerto II CRT-D | Medtronic, Inc. Mounds View, MN 55112 | Modifications to the outlier criteria for the Open Circuit Voltage (OCV) test. |
| P010031/S142 2/25/09 |
Concerto Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
Medtronic, Inc. Mounds View, MN 55112 | Change to the final device test used on multiple product families. |
| P020004/S042 2/18/09 | GORE Excluder AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 | Modifications to the Limulus Amebocyte Lysate (LAL) sampling plan to allow for testing of three devices from the two approved manufacturing facilities in one pooled elution batch. |
| P020004/S043 2/13/09 | GORE Excluder AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 | Additional packaging locations within the same complex of buildings. |
| P020056/S010 2/27/09 | Allergan Natrelle Silicone-Filled Breast Implants | Allergan Goleta , CA 93117 |
Change in the supplier of components for the manufacture of the device. |
| P030002/S018 2/26/09 | Crystalens® Model AT-45 Accommodating Intraocular Lens | Bausch & Lomb, Inc. Aliso Viejo , CA 92656 |
Implementation of an alternate component cleaning method. |
| P030035/S054 2/27/09 | Aescula Family of Left Heart Leads | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sylmar , CA 91342 |
Addition of an alternate semi-automated packaging process. |
| P030052/S003 2/25/09 | UroVysion™ Bladder Cancer Kit | Abbott Molecular, Inc. Des Plaines , IL 60018 |
Change to scale up the production of cell paste used to prepare probes to reduce manufacturing time. |
| P030054/S115 2/27/09 | QuickSite and QuickFlex Family of Leads | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sylmar , CA 91342 |
Addition of an alternate semi-automated packaging process. |
| P040024/S033 2/12/09 | Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale , AZ 85256 | Change in the cleaning frequency of the water softeners and membranes of the purified water system for the manufacture of Restylane® and Perlane® Injectable Gels. |
| P040027/S013 2/13/09 | GORE VIATORR TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 | Additional packaging locations within the same complex of buildings. |
| P040037/S015 2/26/09 | GORE VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 | Changes to the packaging component for the device. |
| P040037/S016 2/13/09 | GORE VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 | Additional packaging locations within the same complex of buildings. |
| P040038/S017 2/23/09 | Xact® Carotid Stent System | Abbott Vascular, Inc. Santa Clara , CA 95054 |
Change to the static wire bond and a change to the adhesive drying time. |
| P040043/S027 2/13/09 | GORE TAG Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 | Additional packaging locations within the same complex of buildings. |
| P050006/S010 2/13/09 | GORE Helex Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 | Additional packaging locations within the same complex of buildings. |
| P050037/S019 2/25/09 | Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville , WI 53126 |
Evaluation of re-qualification of sterilizer after maintenance. |
| P050047/S006 2/6/09 | Juvederm Hyaluronate Gel Implants | Allergan, Inc. Goleta , CA 93117 |
Change in mixing cartridges. |
| P050052/S021 2/25/09 | Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville , WI 53126 |
Evaluation of re-qualification of sterilizer after maintenance. |
| P060025/S004 2/19/09 | ATS 3f® Aortic Bioprosthesis | ATS Medical, Inc. Lake Forest , CA 92630 | Change to the tissue fixation process. |
| P060027/S010 2/23/09 | Ovatio CRT 6750 CRT-D | ELA Medical, Inc. Plymouth , MN 55441 | Change in the type of x-ray machine. |
| P070015/S011 2/11/09 | XIENCE V™ Everolimus Eluting Coronary Stent System | Abbott Vascular, Inc. Temecula , CA 92591 |
Increase of the retesting interval for purified poly (n-butyl methacrylate). |
| P080007/S001 2/26/09 | E-LUMINEXX Vascular Stent | Bard Peripheral Vascular, Inc. Tempe , AZ 85280 |
Modifications to the manufacturing process for a delivery system component. |
| P070015/S011 2/11/09 | XIENCE V™ Everolimus Eluting Coronary Stent System | Abbott Vascular, Inc. Temecula , CA 92591 |
Increase of the retesting interval for purified poly (n-butyl methacrylate). |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 60
Summary of PMA Originals Under Review
Total Under Review: 68
Total Active: 33
Total On Hold: 35
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 521
Total Active: 364
Total On Hold: 157
Number Greater Than 180 Days: 20
Summary of All PMA Submissions Received
Originals: 2
Supplements: 182
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 60
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 124.4
FDA Time: 89.4 Days MFR Time: 35 Days
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