Medical Devices

June 2009 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

None.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
N18286/S018 6/10/09 180-Day	Gelfoam Plus Hemostasis Kit	Pfizer, Inc. New York, NY 10017	Approval of changes to the manufacturing of the human thrombin component of the Gelfoam Plus Hemostasis Kit through the addition of a solvent/ detergent step (Human Thrombin VH S/D). The thrombin is to be manufactured and supplied by Baxter Healthcare Corporation.
P830063/S005 6/19/09 180-Day	PRISMA TPE 2000 Set	Gambro Renal Products Lakewood, CO 80215	Approval for the following modifications to the PRISMA TPE 2000 set: 1) direct connection of the plasmafilter to the cartridge plate via the dialysate connectors; 2) optimization and simplification of the tubing circuit; 3) the plasmafilter oriented parallel to the cartridge plate; 4) the lines fixed by pawl and ratchet mechanism; 5) the pump segment fixed by clicking via a specific joint connector; and 6) blood lines screwed by connectors to the blood port filter.
P840001/S126 6/3/09 180-Day	Restore PRIME Model 37701, PrimeADVANCED Model 37702, Restore Rechargeable, Restore ADVANCED Model 37711, and Rechargeable Model 37713	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for Model 39565 Specify 5-6-5 Lead Kit (65cm length), Model 39286 Specify 2x8 Surgical Lead Kit (30cm and 65cm lengths), and Model 3550-P4 Passing Elevator Accessory Kit.
P840001/S136 6/8/09 Real-Time	Restore Family of Neurostimulation Devices	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for minor modifications to the torque wrench and stylet accessories.
P840062/S019 6/9/09 180-Day	CollaPlug Absorbable Collagen Wound Dressing	Integra LifeSciences Corporation Plainsboro, NJ 08536	Approval for an additional trade name, OraPlug, to the CollaPlug Absorbable Collagen Wound Dressing.
P890003/S164 6/24/09 135-Day	Prodigy IPG	Medtronic, Inc. Mounds View, MN 55112	Approval of a new leak tester.
P900023/S051 6/5/09 Real-Time	i Pulse Circulatory Support System	Abiomed, Inc. Danvers, MA 01923	Approval for an increased field service interval of 5000 hours for the iPulse Console.
P930021/S011 6/19/09 180-Day	Emdogain	The Straumann Company Andover, MA 01810	Approval for the following: 1) the use of Straumann Emdogain with bone substitute material, such as Straumann bone Ceramic; 2) labeling changes to modify a statement regarding the long term stability of regenerated tissue; 3) labeling change to add additional surgical techniques for the treatment of gingival recession defects; 4) labeling change to include instructions in the “Storage” section in Instructions for Use for homogenization if the material is separated in the syringe; and 5) clarify the instructions under each of the three Clinical Procedures in the Instructions for Use to better align them with one another.
P950021/S011 6/10/09 180-Day	Advia Centaur XP PSA assay on the Advia Centaur XP (with version 5.0 software)	Siemens Healthcare Diagnostic, Inc. Tarrytown, NY 10591	Approval for the addition of the Advia Centaur XP instrument (with version 5.0 software) to the instrument(s) using the Advia Centaur PSA assay. The device, as modified, will be marketed under the trade name ADVIA Centaur and ADVIA Centaur XP PSA assay and is indicated for the measurement of serum PSA in conjunction with Digital Rectal Exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. Prostate biopsy is required for the diagnosis of prostate cancer. This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer.
P950022/S055 6/18/09 135-Day	Durata, Riata ST Optim, and Riata ST Families of Defibrillation Leads	St. Jude Medical, Inc. Sylmar, CA 91342	Approval of an automated heat shrinking process.
P950029/S041 6/11/09 180-Day	Esprit Models SR and DR Pacemaker Systems with the programmer application software version Smartview 2.16 UG1	ELA medical, Inc. / Sorin Group Plymouth, MN 55441	Approval for the Esprit Models SR and DR Pacemaker Systems with the programmer application software version Smartview 2.16 UG1.
P960004/S042 6/5/09 Real-Time	FINELINE II / ThinLine2 Family of Brady Leads	Boston Scientific Cardiac Rhythm Management St. Paul, MN 55112	Approval for the addition of a new supplier, Optinova, and changes in specifications for foreign matter, gels, and bubbles for the polyurethane tubing lead body used in the device.
P960009/S067 6/8/09 Real-Time	ActivaRC and ActivaPC	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for Model 64001 (1x4) Pocket Adaptor and Model 64002 (2x4) Pocket Adaptor.
P960013/S043 6/29/09 135-Day	1888 Tendril Family of Leads	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342	Approval for an alternate supplier of lead components.
P960040/S195 6/12/09 Real-Time	RF Module Changes for COGNIS/TELIGEN Models E102, E110, N108, N118, and N119	Boston Scientific Corporation St. Paul, MN 55112	Approval for the RF Module Changes for COGNIS/TELIGEN Models E102, E110, N108, N118, and N119.
P9600058/S075 6/12/09 135-Day	HiResolution Bionic Ear System	Advanced Bionics Sylmar, CA 91342	Approval for improvements to the manufacturing process for the Magnet Assembly used in the HiRes90K Implantable Cochlear Stimulator.
P970012/S051 6/24/09 135-Day	Kappa IPGs	Medtronic, Inc. Mounds View, MN 55112	Approval of a new leak tester.
D970012/S065 6/11/09 180-Day	AMS 700® Series Inflatable Penile Prosthesis with INHIBIZONE®	American Medical Systems, Inc. Minnetonka, MN 55343	Approval for modifications to the physician and patient labeling to summarize the results of the INHIBIZONE® postapproval study.
P980016/S179 6/24/09 135-Day	Marquis ICDs, Maximo ICDs, Intrinsic ICDs, EnTrust ICDs, Virtuoso ICDs, Maximo II ICDs, Secura ICD, and Virtuoso II ICD	Medtronic, Inc. Mounds View, MN 55112	Approval of a new leak tester.
P980016/S191 6/24/09 180-Day	EnTrust ICD Family	Medtronic, Inc. Mounds View, MN 55112	Approval for version 7.1 of the Model 9987 application software which resets the ERI voltage threshold to compensate for the potential premature lithium depletion.
P980022/S046 6/19/09 Real-Time	MiniLink Real-Time Transmitter & CGMS iPRO Digital Recorder	Medtronic MiniMed, Inc. Northridge, CA 91325	Approval for the following modifications to the MiniLink Real-Time Transmitter & CGMS iPRO Digital Recorder: addition of a shelf mode, battery under voltage protection, electrostatic discharge (ESD) protection, removal of the disconnect test, and a new housing.
P980035/S128 6/24/09 135-Day	Kappa IPGs, Sigma IPGs, EnPulse IPGs, EnRhythm IPGs, AT500 Pacing System, Adapta/Sensia/ Versa IPGs, and Relia IPG	Medtronic, Inc. Mounds View, MN 55112	Approval of a new leak tester.
P980035/S136 6/24/09 180-Day	EnRhythm IPG Family	Medtronic, Inc. Mounds View, MN 55112	Approval for version 7.1 of the Model 9987 application software which resets the ERI voltage threshold to compensate for the potential premature lithium depletion.
P980037/S030 6/24/09 Real-Time	AngioJet® Rheolytic™ Thrombectomy System	MEDRAD Interventional / Possis Minneapolis, MN 55433	Approval for a change to the AngioJet Ultra Console bar code reader.
P990001/S050 6/24/09 135-Day	C-series IPGs, T-series IPGs, and Dema Family	Medtronic, Inc. Mounds View, MN 55112	Approval of a new leak tester.
P990027/S012 6/26/09 180-Day	Bausch & Lomb Technolas® 217z Zyoptix System	Biomed Research, Inc. Lutz, FL 33558	Approval for a manufacturing site change located at Technolas Perfectvision GmbH, Munich, Germany.
P990055/S012 6/10/09 180-Day	Advia Centaur XP cPSA assay on the Advia Centaur XP (with version 5.0 software)	Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591	Approval for the addition of the Advia Centaur XP instrument (with version 5.0 software) to the instrument(s) using the Advia Centaur cPSA assay. The device, as modified, will be marketed under the trade name ADVIA Centaur and ADVIA Centaur XP cPSA assay and is indicated for the measurement of serum complexed PSA in conjunction with Digital Rectal Exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. Prostate biopsy is required for the diagnosis of prostate cancer. This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer.
P000021/S014 6/4/09 Real-Time	Dimension RxL® Max® TPSA Flex® Reagent Cartridge	Siemens Healthcare Diagnostics, Inc. Newark, DE 19714	Approval for the use of the Dimension® TPSA Flex® reagent cartridge on the Dimension® RxL Max® with ADVIA® Modular Automation Systems (AMAS) (ADVIA® LabCell® and ADVIA® WorkCell).
P000025/S042 6/12/09 Real-Time	SONATA TI 100 Implant	MED-EL Corporation Durham, NC 27713	Approval for the Implant Template, Single Use for the SONATA TI 100 Implant (SONATA TI 100 Template SU).
P010003/S014 6/26/09 Real-Time	BioGlue Surgical Adhesive	CryoLife, Inc. Kennesaw, GA 30144	Approval for printing the product name on the syringe body.
P010012/S182 6/25/09 180-Day	ACUITY Spiral Heart Failure Leads	Guidant Corporation St. Paul, MN 55112	Approval of the post-approval study protocol.
P010012/S209 6/12/09 Real-Time	COGNIS/TELIGEN Models E102, E110, N108, N118, and N119	Boston Scientific Corporation St. Paul, MN 55112	Approval for the RF Module Changes for COGNIS/TELIGEN Models E102, E110, N108, N118, and N119.
P010015/S062 6/24/09 135-Day	InSync CRT-P and InSync II CRT-P	Medtronic, Inc. Mounds View, MN 55112	Approval of a new leak tester.
P010015/S068 6/5/09 Real-Time	Medtronic Attain® Bipolar Over-the-Wire (OTW) Lead	Medtronic, Inc. Mounds View, MN 55112	Approval for a change to the DC resistance specification for the Model 4194 Attain® Bipolar Over-the-Wire (OTW) lead family.
P010031/S143 6/24/09 135-Day	InSync II Marquis ICDs, InSync III Marquis ICDs, InSync II Protect ICDs, InSync III Protect ICDs, InSync Sentry ICDs, InSync Maximo ICDs, Concerto CRT-D, Maximo II CRT-D, Consulta CRT-D, Concerto II CRT-D, InSync ICD, and InSync Marquis ICD	Medtronic, Inc. Mounds View, MN 55112	Approval of a new leak tester.
P010032/S029 6/1/09 Real-Time	Eon Neurostimulation (IPG), ANS Eon C Neurostimulation (IPG), and Eon mini Neurostimulation (IPG)	Advanced Neuromodulation Systems Plano, TX 75024	Approval for Penta lead kits (models 3227, 3228, 3229, 3230, 3231, 3232, 3233, and 3234).
P010050/S008 6/2/09 Real-Time	Immulite / Immulite 1000 HBsAg Assay and Immulite 2000 HBsAg Assay	Siemens Healthcare Diagnostics Los Angeles, CA 90045	Approval for revisions to the product labeling to include a “hot zone cutoff” under the Interpretation of Results section. This “hot zone cutoff” establishes a level at which high HBsAg reactive samples may be reported as reactive without confirmatory testing.
P010055/S006 6/8/09 180-Day	CoreTherm System Microwave Thermotherapy for BPH	ProstaLund Operations, AB Lund, Sweden SE-226 60	Approval for a manufacturing site located at Cenova Innovation and Production AB in Mjolby, Sweden, where catheter packaging will be performed.
P020014/S027 6/19/09 Special	Conceptus Essure® System for Permanent Birth control	Conceptus, Inc. Mountain View, CA 94041	Approval for changes to the physician labeling regarding perforation and hypervolemia.
P030002/S019 6/30/09 Real-Time	Crystalens® Model AT-45 Accommodating Intraocular Lens (IOL)	Bausch & Lomb, Inc. Aliso Viejo, CA 92656	Approval to modify the Physician’s labeling to include the addition of 0.25 diopter increments for the Crystalens Model HD500 and HD520 as follows: the addition of 0.25 diopter increments for Model HD500 lenses in the +18 to +22 dioptric power range and for Model HD520 lenses in the +16.25 to +16.75 dioptric power range.
P030006/S021 6/19/09 135-Day	Prolieve Thermodilitation System	Boston Scientific Corporation Urology/ Gynecology Marlborough, MA 01752	Approval for modification to the welding process that is used to bond the catheter tip to the catheter extrusion for the Prolieve treatment catheter.
P030010/S004 6/4/09 Special	Siemens Mammomat Novation DR Full Field Digital Mammography System	Siemens Medical Solutions USA, Inc. Malvern, PA 19355	Approval for labeling changes.
P030017/S091 6/19/09 180-Day	PRECISION™ Spinal Cord Stimulation (SCS) System	Boston Scientific Corporation Valencia, CA 91355	Approval for the Remote Control SC-5212.
P030029/S004 6/10/09 180-Day	ADVIA® Centaur Anti-HBs (aHBs) Assay	Siemens Healthcare Diagnostics Tarrytown, NY 10591	Approval for adding quantitative determination of total antibodies to hepatitis B surface antigen in human adult, adolescent, and pediatric serum or plasma to the intended use. The device, as modified, will be marketed under the trade name ADVIA Centaur® and ADVIA Centaur® XP anti-HBs Assay and is indicated for: The ADVIA Centaur Anti-HBs assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis B surface antigen in human adult, adolescent, and pediatric serum or plasma (EDTA or heparinized) using the ADVIA Centaur and ADVIA Centaur XP systems. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with I HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.
P040014/S008 6/17/09 180-Day	Therapy Cardiac Ablation Catheters	Irvine Biomedical, Inc. Irvine, CA 92614	Approval for software changes in the IBI 1500T9 RF Generator with software version 1.42.
P040033/S011 6/9/09 Real-Time	Birmingham Hip Resurfacing (BHR) System	Smith & Nephew Orthopaedics Memphis, TN 38116	Approval for the modification of the BHR/R3 Modular Resurfacing Surgical Technique Addendum.
P040037/S013 6/25/09 180-Day	Gore Viabahn® Endoprosthesis	W.L. Gore & Associates, Inc. Flagstaff, AZ 86001	Approval to modify the design platform of the large diameter device (9-13mm diameter) so that it is identical to the currently approved smaller diameter devices. The design platform modification includes changes to the delivery system and associated manufacturing changes.
P040042/S013 6/17/09 180-Day	Therapy Dual 8/Therapy & Safire TX Ablation Catheters	Irvine Biomedical, Inc. Irvine, CA 92614	Approval for software changes in the IBI 1500T9 RF Generator with software version 1.42.
P040047/S013 6/24/09 135-Day	Coaptite® Injectable Implant	BioForm Medical, Inc. Franksville, WI 53126	Approval for the requalification of the Getinge 6612AR1 sterilizer.
P040050/S003 6/26/09 180-Day	Macroplastique Implants	Uroplasty, Inc. Minnetonka, MN 55343	Approval for labeling modifications to reflect the findings of the Enhanced Surveillance study.
P050018/S007 6/19/09 Special	AngioSculpt® PTCA Scoring Balloon Catheter	AngioScore, Inc. Fremont, CA 94538	Approval for the addition of further user instructions in the Instructions for Use (IFU) to enhance the safe use of the monorail (easy exchange) delivery platform of the AngioSculpt Scoring Balloon Catheter.
P050033/S007 6/1/09 180-Day	Hydrelle™	Anika Therapeutics, Inc. Bedford, MA 01730	Approval for a change in the device name from Elevess™ to Hydrelle™.
P050042/S005 6/23/09 180-Day	ARCHITECT Anti-HCV Assay, ARCHITECT Anti-HCV Calibrator and ARCHITECT Anti-HCV Control	Abbott Diagnostics Abbott Park, IL 60064	Approval to extend the application of the ARCHITECT Anti-HCV Assay, currently approved for use on the Abbott ARCHITECT i2000/ i 2000SR, onto a new ARCHITECT i system family member, the ARCHITECT i 1000SR.
P050046/S004 6/26/09 135-Day	Acuity Steerable Lead	Guidant Corporation St. Paul, MN 55112	Approval of a new pull tester.
P060007/S003 6/5/09 Special	Abbott Architect HBsAg Reagent	Abbott Diagnostics Abbott Park, IL 60064	Approval for implementation of a new quality control testing procedure with a 100-member panel for the Architect HBsAg reagent conjugate.
P060010/S007 6/26/09 Real-Time	The Spanner™ Temporary Prostatic Stent	AbbeyMoor Medical, Inc. Parkers Prairie, MN 56351	Approval for modification of the Spanner Proximal Tube Assembly to replace the stainless steel coil with a high durometer silicone sleeve.
P060019/S005 6/12/09 180-Day	Therapy™ Cool Path™ Ablation Catheter & IBI-1500T9-CP RF Ablation Generator (software version 1.42) & Cool Point Pump	Irvine Biomedical, Inc. Irvine, CA 92614	Approval for use of the Cool Point Pump and tubing set to provide irrigation of the Therapy™ Cool Path™ Ablation Catheter as well as modification to the IBI 1500T9 RF Ablation Generator to function with the Cool Point Pump. The device, as modified, will be marketed under the trade name IBI-1500T9-CP RF Ablation Generator.
P060035/S001 6/23/09 180-Day	ARCHITECT® CORE-M™ Reagent Kit, ARCHITECT® CORE-M™ Calibrators and ARCHITECT® CORE-M™ Controls	Abbott Laboratories Abbott Park, IL 60064	Approval for migration of the ARCHITECT® CORE-M™ assay to a new ARCHITECT ® i System family member, the ARCHITECT® i1000 SR.
P060037/S010 6/19/09 Special	Zimmer NexGen® LPS-Flex Mobile and LPS-Mobile Bearing Knee Systems	Zimmer, Inc. Warsaw, IN 46581	Approval for: 1) adding a verification step to use a poke-yoke fixture to sort product during manufacturing; and 2) adding a step to verify the spiralock thread function.
P070013/S003 6/5/09 180-Day	Evolence® Collagen Filler	Johnson & Johnson Consumer and Personal Products Worldwide Skillman, NJ 08558	Approval for labeling changes based on the additional clinical 12 month safety and efficacy data submitted to extend the initial 6 month safety and efficacy data.
P080010/S001 6/12/09 180-Day	Tecnis® Multifocal Foldable Posterior Chamber Intraocular Lens (IOL)	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Approval for changes to the labeling for the Tecnis® Multifocal Foldable Posterior Chamber Intraocular Lens (IOL), Models ZM900 and ZMA00, revision the Directions for Use (DFU) and the patient brochure for the lens models with updated one-year follow up data from the clinical investigation for the lenses.
P080010/S002 6/19/09 180-Day	Tecnis® Multifocal Foldable Acrylic Intraocular Lens (IOL)	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Approval for an alternate manufacturing site located at AMO Puerto Rico Manufacturing, Inc., Anasco, Puerto Rico.

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
P840001/S138 6/18/09	Model 3550-31 Snap-Lid Screening Connector Cable	Medtronic Neuromodulation Minneapolis, MN 55432	Changes to the manufacturing process of the screening connector cable.
P880047/S013 6/24/09	Interceed Absorbable Adhesion Barrier	Ethicon, Inc. Somerville, NJ 08876	Modification of a processing aid in the manufacturing of the device.
P880086/S175 6/12/09	Accent/Zephyr/ Victory Pacemakers	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086	Alternate supplier for the low voltage hybrid assembly.
P910001/S031 6/1/09	Spectranetics CVX-300™ Coronary Laser Catheter	Spectranetics Corporation Colorado Springs, CO 80921	Changes to the in-process acceptance activities for the labeling and boxing process.
P910023/S210 6/10/09	Current/Current+ ICD	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342	Change in bake time of the flex circuit component.
P910023/S211 6/18/09	Cadence Family of ICDs	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342	Modification of the placement process of the telemetry coil substrate onto the nylon support assembly.
P910073/S078 6/10/09	Endotak Reliance Tachy Lead	Guidant Corporation St. Paul, MN 55112	Addition of an alternate supplier for the Molded Terminal Lead Connector.
P930014/S032 6/10/09	AcrySof® Toric Intraocular Lenses	Alcon Research, Ltd. Fort Worth, TX 76134	Change to the mechanical focusing mechanism on the lens benches used in the manufacture of the device.
P930014/S033 6/10/09	AcrySof® Posterior Chamber Intraocular Lenses	Alcon Research, Ltd. Fort Worth, TX 76134	Change in manufacturing equipment.
P930029/S022 6/10/09	RF Conductor Ablation Catheters	Medtronic, Inc. Mounds View, MN 55112	Change to the wire bending manufacturing process.
P960040/S196 6/3/09	Teligen ICD	Boston Scientific St. Paul, MN 55112	Addition of a second source supplier for the Crystal Quartz.
P960040/S200 6/26/09	Teligen Family of AICDs	Boston Scientific St. Paul, MN 55112	Changes to: 1) move the fabrication of the L-tab from an outside vendor to in-house; 2) etch the tab instead of stamping it; 3) add an aluminum sheet metal contractor; and 4) revise two dimensions of the tab.
P960042/S013 6/1/09	Spectranetics Laser Sheath (SLS)	Spectranetics Corporation Colorado Springs, CO 80921	Changes to the in-process acceptance activities for the labeling and boxing process.
P960058/S081 6/12/09	HiResolution Bionic Ear System	Advanced Bionics Sylmar, CA 91342	Change to the HiRes90K inductor attachment process.
P970008/S044 6/24/09	Urologix Targis® System	Urologix, Inc. Minneapolis, MN 55447	Addition of an adhesive to the manufacturing of a control unit.
P970021/S027 6/19/09	Gynecare Thermachoice® III Uterine Balloon Therapy System	Ethicon Women’s Health & Urology Somerville, NJ 08876	Use of a new sub-tier supplier during the manufacturing of the device.
P980016/S194 6/17/09	Marquis ICD, Maximo ICD, Intrinsic ICD, EnTrust ICD, Virtuoso ICD, Virtuoso II ICD, Secura ICD, Maximo II ICD	Medtronic, Inc. Mounds View, MN 55112	Addition of a new back fill laser weld unit.
P980022/S055 6/16/09	MiniLink Real-Time Transmitter	Medtronic MiniMed, Inc. Northridge, CA 91325	Change to the housing of the device.
P010012/S210 6/3/09	Cognis CRT-D	Boston Scientific St. Paul, MN 55112	Addition of a second source supplier for the Crystal Quartz.
P010012/S214 6/26/09	COGNIS Family of AICDs	Boston Scientific St. Paul, MN 55112	Changes to: 1) move the fabrication of the L-tab from an outside vendor to in-house; 2) etch the tab instead of stamping it; 3) add an aluminum sheet metal contractor; and 4) revise two dimensions of the tab.
P010012/S215 6/30/09	CONTAK RENEWAL	Boston Scientific St. Paul, MN 55112	Adding a Vacuum Bake Process to the manufacturing rework process.
P010031/S155 6/17/09	InSync II Marquis, InSync III Marquis, InSync II Protect, InSync III Protect, InSync Sentry, InSync Maximo ICD Family, Concerto CRT-D, Consulta CRT-D, Maximo II CRT-D, and Concerto II CRT-D	Medtronic, Inc. Mounds View, MN 55112	Addition of a new back fill laser weld unit.
P020014/S025 6/11/09	Conceptus Essure System	Conceptus, Inc. Mountain View, CA 94041	Change to the manufacturing of the mechanism that holds the inner catheter subassembly release ribbon in place.
P020036/S015 6/18/09	SMART® Control Nitinol Stent System	Cordis Corporation Bridgewater, NJ 08807	Addition of a packaging inspection step.
P030026/S018 6/12/09	VITROS Immunodiagnostic Product Anti-HBc IgM Reagent Packs and Calibrators	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626	Extension of the shelf-life of the positive serum used in the manufacturing of VITROS Anti-HBc Calibrator to 2 years (36 months).
P030035/S055 6/12/09	Anthem/Frontier II CRT-Ps	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086	Alternate supplier for the low voltage hybrid assembly.
P030047/S018 6/18/09	Cordis Precise®, Precise® Rx, Precise® Pro Rx Nitinol Stent System	Cordis Corporation Bridgewater, NJ 08807	Addition of a packaging inspection step.
P030054/S125 6/10/09	Promote/Promote+ CRT-D	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342	Change in bake time of the flex circuit component.
P030054/S126 6/18/09	Epic HF/Atlas+ HF Family of CRT-Ds	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342	Modification of the placement process of the telemetry coil substrate onto the nylon support assembly.
P040014/S010 6/1/09	Therapy Cardiac Ablation Catheter	St. Jude Medical, Inc. Irvine, CA 92614	Change to realign the hypo tube.
P040020/S016 6/10/09	AcrySof® IQ ReSTOR® Intraocular Lenses	Alcon Research, Ltd. Fort Worth, TX 76134	Extension of two (2) work-in-process queue times for the device.
P040020/S017 6/10/09	ReSTOR® Posterior Chamber Intraocular Lenses	Alcon Research, Ltd. Fort Worth, TX 76134	Change in manufacturing equipment.
P040021/S009 6/24/09	St. Jude Medical Biocor™, Biocor™ Supra, Epic™, and Epic™ Supra Heart Valves	St. Jude Medical, Inc. St. Paul, MN 55128	Change in the supplier for the polyester suture.
P040024/S040 6/10/09	Restylane® and Perlane® Injectable Gels	Medicis Pharmaceutical Corporation Scottsdale, AZ 85256	Change in the analyzing laboratory for identity testing of a raw material.
P040037/S019 6/10/09	Gore VIABAHN® Endoprosthesis	W.L. Gore & Associates, Inc. Flagstaff, AZ 86001	Change from a manual to an automated process for trimming the excess ePTFE graft material.
P040042/S015 6/1/09	Therapy Dual 8 Ablation Catheter	St. Jude Medical, Inc. Irvine, CA 92614	Change to realign the hypo tube.
P040045/S005 6/19/09	VISTAKON® (senofilcon A) Contact Lenses	Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256	Change in a quality control test method for the finished device.
P050020/S015 6/24/09	Freestyle Navigator® Continuous Glucose Monitoring System	Abbott Diabetes Care, Inc. Alameda, CA 94502	Change to the mold temperature.
P060008/S018 6/25/09	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Modifications to the manufacturing process for the drug coating.
P060019/S008 6/1/09	Therapy Cool Path Ablation Catheter	St. Jude Medical, Inc. Irvine, CA 92614	Change to realign the hypo tube.
P070015/S018 6/16/09	XIENCE V® Everolimus-Eluting Coronary Stent System (EECSS)	Abbott Vascular Temecula, CA 92590	Change to the in-process acceptance activities in the reference standard specification document.
P070015/S020 6/23/09	XIENCE V® Everolimus-Eluting Coronary Stent System (EECSS)	Abbott Vascular Santa Clara, CA 95054	Changes to quality engineering testing for the device.

Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 61

Summary of PMA Originals Under Review
Total Under Review: 70
Total Active: 37
Total On Hold: 33
Number Greater Than 180 Days: 4

Summary of PMA Supplements Under Review
Total Under Review: 443
Total Active: 307
Total On Hold: 136
Number Greater Than 180 Days: 15

Summary of All PMA Submissions Received
Originals: 3
Supplements: 37

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 61
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 134.7
FDA Time: 113.9 Days MFR Time: 20.8 Days

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June 2009 PMA Approvals

PMA Original Approvals

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