Premarket Approval Decisions for July 2005

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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PMA Final Decisions Rendered for July 2005

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��

P030004
7/21/05

Onyx® Liquid Embolic System (LES)

Micro Therapeutics, Inc.
Irvine, CA
92618

Approval for the Onyx Liquid Embolic System (LES). The device is indicated for presurgical embolization of brain arteriovenous malformations.

PMA Supplemental Approvals

N12159/S020 7/22/05 180-Day	SURGICEL™/ SURGICEL™ NU-KNIT/ SURGICEL™ Fibrillar Absorbable Hemostat	Johnson & Johnson Wound Management Worldwide A Div of ETHICON, Inc. Somerville, NJ 08876	Approval for a sterilization site located at Steris Isomedix Services, Whippany, New Jersey.
P830079/S016 7/22/05 180-Day	INSTAT™ Collagen Hemostat	Johnson & Johnson Wound Management Worldwide A Div of ETHICON, Inc. Somerville, NJ 08876	Approval for a sterilization site located at Steris Isomedix Services, Whippany, New Jersey.
P870038/S005 7/20/05 Real-Time	Starr-Edwards Silastic Ball Prosthesis, Models 1260 & 6120	Edwards Lifesciences Irvine, CA 92614	Approval for an alternate supplier of polyethylene tetrafluoroethylene (PTFE) thread, namely W.L. Gore, and for a change from multifilament PTFE thread to monofilament PTFE thread used in the final sewing of the cloth to complete the sewing ring of the Starr-Edwards Silastic Ball Prosthesis, Models 1260 & 6120.
P880047/S009 7/22/05 180-Day	INTERCEED™ (TC7) Absorbable Barrier	GYNECARE, A Div. Of ETHICON, Inc. Somerville, NJ 08876	Approval for a sterilization site located at Steris Isomedix Services, Whippany, New Jersey.
P890003/S082 7/26/05 180-Day	Medtronic 2020A CardioSight Reader and the Model 2491 Device Data Management Application (DDMA) Software	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic 2020A CardioSight Reader and the Model 2491 Device Data Management Application (DDMA) Software for use in the transfer of patient and device data.
P890003/S087 7/18/05 Real-Time	Medtronic Model 2490G CareLink Monitors and Model 2491 DDMA Software for InSync Sentry Model 7299, InSync Maximo Model 7304, and the V-V timing feature for both the InSync Sentry Model 7297 and the InSync Maximo Model 7303	Medtronic, Inc. Minneapolis, MN 55432	Approval for the CareLink Monitor Model 2490G for use with additional pulse generator models, specifically the InSync Sentry Model 7299, InSync Maximo Model 7304, and the V-V timing feature for both the InSync Sentry Model 7297 and the InSync Maximo Model 7303. The CareLink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.
P910066/S021 7/19/05 Real-Time	SpinaLogic 1000 Bone Growth Stimulator	dj Orthopedics, LLC Vista, CA 92083	Approval for the described coil modifications including geometric changes, turn schedule changes, and manufacturing changes. The device, as modified, will be marketed under the trade name SpinaLogic 1000 Bone Growth Stimulator and is indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
P950020/S010 7/18/05 180-Day	Flextome Cutting Balloon™ Monorail (MR)/Over-the-Wire (OTW)	Boston Scientific IVT San Diego, CA 92123	Approval for design, manufacturing, and labeling changes in the Cutting Balloon, both Over-the-Wire (OTW) and Monorail (MR) configurations. The device, as modified, will be marketed under the trade name Flextome Cutting Balloon™ and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered.
P950027/S006 7/19/05 Real-Time	Hyalgan®	Fidia Farmaceutical, S.p.A. Via Ponte Della Fabbrica, Italy	Approval for modifying the specifications for the active ingredient (sodium hyaluronate) by eliminating the abnormal toxicity test and replacing the rabbit pyrogen test with the bacterial endotoxins test (Limulus Amoebocyte Lysate (LAL) test) and modifying the specifications for the finished product to replace the rabbit pyrogen test with the LAL test.
P960040/S066 7/29/05 Real-Time	VENTAK PRIZM 2 DR AICD Model 1861	Guidant Corporation CRM St. Paul, MN 55112	Approval to replace the existing Polyimide tubing that provides insulation in the pulse generator header assembly with Polyetheretherke-tone (PEEK) tubing.
P960040/S067 7/27/05 Real-Time	VITALITY HE Models T180 and T182	Guidant Corporation CRM St. Paul, MN 55112	Approval for 1) An alternate magnetic reed switch manufactured by Hermetic and an associated change to the equipment used in the rework of the component; and 2) Programmer Software Application Model 2845 v2.8.
P960058/S045 7/25/05 180-Day	HiResolution Bionic Ear System	Advanced Bionics Corporation Sylmar, CA 91342	Approval for an updated Auria PowerPak assembly configuration.
P960058/S046 7/14/05 Real-Time	HiResolution Bionic Ear System	Advanced Bionics Corporation Sylmar, CA 91342	Approval for a new Auria earhook, the iConnect, to provide an ear-level, cable-free interface for third-party miniature FM receivers.
P970003/S050 7/15/05 Panel	VNS Therapy System	Cyberonics, Inc. Houston, TX 77058	Approval for the VNS Therapy System. The device is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
P970015/S029 7/22/05 Real-Time	LT-Cage® Lumbar Tapered Fusion Device	Sofamor Danek USA Memphis, TN 38132	Approval for the addition of the 14mm x 26mm cage titanium LT-CAGE® Lumbar Tapered Fusion Device. The device remains indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. LT-CAGE® devices are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. Patients receiving the LT-CAGE® Lumbar Tapered Fusion Device should have had at least six months of nonoperative treatment prior to treatment with the LT-CAGE® device.
P970015/S031 7/27/05 180-Day	INTER FIX™ Threaded Fusion Device	Medtronic Sofamor Danek USA Memphis, TN 38132	Approval for the post approval study. The device remains indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. INTER FIX™ implants and INTER FIX™ RP implants are to be used with autogenous bone graft and implanted via an open anterior approach.
P980016/S048 7/26/05 180-Day	Medtronic 2020A CardioSight Reader and the Model 2491 Device Data Management Application (DDMA) Software	Medtronic 2020A CardioSight Reader and the Model 2491 Device Data Management Application (DDMA) Software	Approval for the Medtronic 2020A CardioSight Reader and the Model 2491 Device Data Management Application (DDMA) Software for use in the transfer of patient and device data.
P980022/S011 7/18/05 Panel	Guardian RT	Medtronic MiniMed Northridge, CA 91325	Approval for the Guardian RT. The device is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin in adults (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. It alerts if a glucose level falls below or rises above preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments would be based on measurements obtained using a home glucose monitor and not on Guardian values. Guardian RT provides real-time glucose values that allow users to track patterns in glucose concentrations and to possibly identify episodes of low and high blood glucose episodes. It also stores the data so that it can be analyzed to track patterns. Glucose data can be further downloaded to PC software for analysis of historical glucose values.
P980023/S019 7/18/05 180-Day	Kentrox Family of Implantable Cardioverter Defibrillator Leads, RV, SL, RV-S, SLS	BIOTRONIK, Inc. Lake Oswego, OR 97035	Approval for modifications to the Kentrox family of Implantable Cardioverter Defibrillator (ICD) leads. The devices, as modified, will be marketed under the trade names Kentrox RV, Kentrox RV Steroid, Kentrox SL, Kentrox SL Steroid, Kentrox RV-S, Kentrox RV-S Steroid, and Kentrox SLS Steroid and are indicated for use in conjunction with a BIOTRONIK ICD.
P980035/S044 7/26/05 Real-Time	Kappa 700/650/600, Kappa 900/800, and EnPulse E1/E2 Implantable Pulse Generators	Medtronic, Inc. Minneapolis, MN 55432	Approval for design modifications to the IPG reed switch.
P990066/S020 7/1/05 180-Day	Senographe DS & 2000D Full Field Digital Mammography System	GE Healthcare Waukesha, WI 53188	Approval for software changes to the Senographe DS and (2000D) FFDM Acquition WorkStation (AWS) and Review WorkStation to allow users to select the Premium View (PV) algorithm as primary image processing.
P990071/S007 7/12/05 180-Day	Stockert 70 RF Generator for Cardiac Ablation	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for replacing Software Version 1.034B with version 1.035. The device, as modified, will be marketed under the trade name Stockert 70 RF Generator for Cardiac Ablation and is indicated for use in conjunction with a compatible catheter for cardiac ablation procedures.
P990075/S016 7/27/05 Real-Time	Saline-Filled Mammary Prosthesis and Spectrum® Post-Operatively Adjustable Saline-Filled Mammary Prosthesis	Mentor Corporation Santa Barbara, CA 93111	Approval for 1) new Style 2000 Moderate Plus Profile, which is considered a modification to the existing product ine, with sizes 175cc-800cc; 2) additional sizes of 400cc, 450cc, 500cc, 600cc, 650cc and 800cc for Style 1600; and 3) additional sizes of 350cc, 400cc, 700cc, 770cc, and 800cc for Style 3000. There are no changes to the indications for use.
P000025/S019 7/25/05 Real-Time	COMBI 40+ System with C40+ or PULSARCI100 Cochlear Implants	MED-El Corporation Durham, NC 27713	Approval for the COMBI 40+ System with C40+ or PULSARCI100 Cochlear Implants to update non-essential labeling and a manual for troubleshooting FM systems which may be used ith the TEMPO+.
P000040/S005 7/12/05 Special	HTA™ System	Boston Scientific Corporation Marlborough, MA 01752	Approval for manufacturing process and quality control changes to the adapters used to connect a hysteroscope to the HTA™ System Procedure Sheath.
P010012/S057 7/27/05 Real-Time	CONTAK RENEWAL Model H135; CONTAK RENEWAL 3 Models H170 and H175; CONTAK RENEWAL 3 HE Models H177 and H179 and Programmer Software Application Model 2845 v.2.8	Guidant Corporation CRM St. Paul, MN 55112	Approval for 1) An alternate magnetic reed switch manufactured by Hermetic and an associated change to the equipment used in the rework of the component; and 2) Programmer Software Application Model 2845 v2.8.
P010013/S014 7/22/05 Real-Time	NovaSure® Impedance Controlled Endometrial Ablation System	Cytyc Surgical Products Palo Alto, CA 94303	Approval for a modification to the device performance protocol used to establish the shelf life of the NovaSure Impedance Controlled Endometrial Ablation System. The protocol used to assess package integrity, i.e., PPQ-012, previously approved is unchanged.)
P010031/S020 7/26/05 180-Day	Medtronic 2020A CardioSight Reader and the Model 2491 Device Data Management Application (DDMA) Software	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic 2020A CardioSight Reader and the Model 2491 Device Data Management Application (DDMA) Software for use in the transfer of patient and device data.
P010031/S024 7/18/05 Real-Time	Medtronic Model 2490G CareLink Monitors and Model 2491 DDMA Software for InSync Sentry Model 7299, InSync Maximo Model 7304, and the V-V timing feature for both the InSync Sentry Model 7297 and the InSync Maximo Model 7303	Medtronic, Inc. Minneapolis, MN 55432	Approval for the CareLink Monitor Model 2490G for use with additional pulse generator models, specifically the InSync Sentry Model 7299, InSync Maximo Model 7304, and the V-V timing feature for both the InSync Sentry Model 7297 and the InSync Maximo Model 7303. The CareLink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.
P010055/S001 7/7/05 180-Day	ProstaLund® CoreTherm™ System Microwave Thermotherapy for BPH	ProstaLund Operations AB Lund, Sweden SE-226 60	Approval for technological modifications to the CoreTherm™ System to comply with the new edition of IEC 6061-1-2 “Medical electrical equipment – Part1: general requirements for safety; electromagnetic compatibility requirements and tests” (2nd edition, 2001).
P020014/S009 7/12/05 180-Day	Essure™ System	Conceptus, Inc. San Carlos, CA 94070	Approval for modification of device labeling to include 4- and 5-year effectiveness results and other labeling changes.
P030006/S006 7/22/05 Real-Time	Celsion Prolieve™ Thermodilatation System	Celsion Corporation Columbia, MD 21064	Approval for use of a new computer motherboard to replace an obsolete motherboard currently used in the Prolieve™ Thermodilatation System.
P030010/S001 7/7/05 180-Day	Siemens Mammomat NovationDR Full Field Digital Mammography System	Siemens Medical Solutions, Inc. Malvern, PA 19355	Approval to change the acquisition workstation (AWS) from the currently approved Unix-based SUN workstation with Solaris 8 operating system to a Fujitsu/Siemens M420PC with Syngo operating system and the proposed changes allowing the software drivers for the detector interface (DRUL) to be Windows XP based.
P030025/S017 7/8/05 135-Day	TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval to change the in-process coating weight acceptance criteria. The device, as modified, will be marketed under the trade name TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System and is indicated for improving luminal diameter for the treatment of de novo lesions <28 mm in length in native coronary arteries =2.5 to =3.75 mm in diameter.
P030032/S003 7/1/05 180-Day	Hylaform, Hylaform Plus, Nd Captique	Genzyme Corporation Cambridge, MA 02142	Approval of the post-approval study for the device.
P040020/S001 7/29/05 Real-Time	Acrysof ReSTOR Natural Intraocular Lens (IOL) Models SN60D3 and MN60D3	Alcon Research, Ltd. Fort Worth, TX 76134	Approval for Acrysof ReSTOR Natural Intraocular Lens (IOL) Models SN60D3 and MN60D3 (Level A Modification: addition of chromophore). The device, as modified, will be marketed under the trade name Acrysof ReSTOR Natural IOL and is indicated for primary implantation for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with or without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.

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

P840064/S028 7/29/05	Provisc® Ophthalmic Viscosurgical Device, Provisc® packaged in Duovisc® Viscoelastic System and DisCoVisc™ Ophthalmic Viscosurgical Device.	Alcon Research, Ltd. Fort Worth, TX 76134	Change in the bacterial master seed storage media used by the vendor.
P860004/S072 7/19/05	Medtronic® SynchroMed® II Implantable Programmable Infusion Pump	Medtronic, Inc. Minneapolis, MN 55432	Change in quality control tests used on components in the SynchroMed II pump.
P860004/S073 7/19/05	Medtronic® SynchroMed® II Implantable Programmable Infusion Pump	Medtronic, Inc. Minneapolis, MN 55432	Change in the welding process on the SynchroMed II inner shield.
P880086/S104 7/8/05	Pulse Generator	St. Jude Medical Sylmar, CA 91342	Removal of an automatic washing machine step in the current washing process of pacemakers.
P890047/S017 7/29/05	Provisc® Ophthalmic Viscosurgical Device, Provisc® packaged in Duovisc® Viscoelastic System and DisCoVisc™ Ophthalmic Viscosurgical Device.	Alcon Research, Ltd. Fort Worth, TX 76134	Change in the bacterial master seed storage media used by the vendor.
P910073/S051 7/8/05	Reliance Leads	Guidant Corporation St. Paul, MN 55112	Use of an alternative silicone adhesive in the manufacture of the Reliance family of leads.
P910077/S052 7/8/05	VENTAK MINI	Guidant Corporation St. Paul, MN 55112	Changes in procedures for cytotoxicity and pyrogenicity testing for inspections of incoming components.
P940031/S035 7/21/05	VIGOR, DISCOVERY MERIDIAN	Guidant Corporation St. Paul, MN 55112	Change to Leak Test Software Operator Login for Brady Pulse Generators.
P940031/S036 7/8/05	DISCOVERY, MERIDIAN	Guidant Corporation St. Paul, MN 55112	Changes in procedures for cytotoxicity and pyrogenicity testing for inspections of incoming components.
P940031/S037 7/27/05	Meridian, Discovery	Guidant Corporation St. Paul, MN 55112	Changes to the software used in the automated setscrew preload verification process.
P940031/S038 7/11/05	DISCOVERY/ MERIDIAN	Guidant Corporation St. Paul, MN 55112	Change the distance between the accelerometer’s beam and lid.
P960040/S056 7/7/05	Prizm®, Prizm® 2, Prizm® HE, Vitality®, Vitality® AVT, Vitality® DS, Vitality® 2	Guidant Corporation St. Paul, MN 55112	Removal of a manual audit of an incoming inspection process for IC wafers
P960040/S058 7/21/05	VITALITY ICD Models T125, T127, T135 and VITALITY AVT ICD Model A155	Guidant Corporation St. Paul, MN 55112	Removal of the Time-Limited ZOOM Programmer Test from the manufacturing process.
P960040/S059 7/21/05	Prizm ICDs Models 1850, 1851, 1852, 1853, 1857, 1858 and Vitality ICDs Models 1870, 1871, 1872	Guidant Corporation St. Paul, MN 55112	Change in the set screw preload verification process.
P960040/S061 7/21/05	Prizm, Prizm 2, Vitality, Vitality 2, Vitality AVT	Guidant Corporation St. Paul, MN 55112	Removal of a second cycle of electrical testing for capacitors.
P960040/S062 7/22/05	CONTAK CD family of Cardiac Resynchronization Therapy Defibrillators	Guidant Corporation St. Paul, MN 55112	Alternate supplier of the Trim Resistor Arrays used in the hybrid builds of the PULSAR MAX, VENTAK and CONTAK CD families of devices.
P960040/S063 7/8/05	PRIZM, VENTAK AV, VENTAK VR, VITALITY	Guidant Corporation St. Paul, MN 55112	Changes in procedures for cytotoxicity and pyrogenicity testing for inspections of incoming components.
P960040/S064 7/27/05	Prizm, Prizm HE, Prizm 2, Vitality, Vitality AVT, Vitality DS, Vitality EL	Guidant Corporation St. Paul, MN 55112	Changes to the software used in the automated setscrew preload verification process.
D970003/S033 7/7/05	Insignia I Entra, Nexus I Entra, Insignia I Ultra	Guidant Corporation St. Paul, MN 55112	Removal of a manual audit of an incoming inspection process for IC wafers
D970003/S034 7/8/05	INSIGNIA 1 Implantable Pacemakers, NEXUS 1 Implantable Pacemakers	Guidant Corporation St. Paul, MN 55112	Change in test software at incoming inspection for integrated circuits used with the INSIGNIA and NEXUS pacemaker family of devices.
D970003/S035 7/21/05	INSIGNIA, PULSAR/ PULSAR MAX, VIRTUS, INTELLIS, NXTDS	Guidant Corporation St. Paul, MN 55112	Change to Leak Test Software Operator Login for Brady Pulse Generators.
D970003/S036 7/22/05	PULSAR MAX family of Implantable pacemakers	Guidant Corporation St. Paul, MN 55112	Alternate supplier of the Trim Resistor Arrays used in the hybrid builds of the PULSAR MAX, VENTAK and CONTAK CD families of devices.
D970003/S037 7/8/05	INSIGNIA 1 Implantable Pacemakers	Guidant Corporation St. Paul, MN 55112	Change the visual inspection criteria for jumper chip components to view weld melt from the side.
D970003/S038 7/27/05	Pulsar, Pulsar Max, Pulsar Max II, Discovery II, Insignia I Entra, Insignia I Ultra, Insignia I Plus, Nexus I Entra, Intellis II	Guidant Corporation St. Paul, MN 55112	Changes to the software used in the automated setscrew preload verification process.
D970003/S039 7/8/05	DISCOVERY, INSIGNIA, INTELIS II, NEXUS PULSAR	Guidant Corporation St. Paul, MN 55112	Changes in procedures for cytotoxicity and pyrogenicity testing for inspections of incoming components.
D970003/S040 7/11/05	DISCOVERY/ PULSAR MAX/INSIGNIA/ INTELIS	Guidant Corporation St. Paul, MN 55112	Change the distance between the accelerometer’s beam and lid.
D970012/S026 7/15/05	Model 700 Inflatable Penile Prosthesis	American Medical Systems Minnetonka, MN 55343	Move a quality control step (Receiving Inspection Screening Test) to after a cross-linker (catalyst) is premixed into the silicone dispersion by the supplier and received by American Medical Systems.
P980018/S004 7/13/05	HercepTest™	DakoCytomation Denmark A/S Glostrup, Denmark DK-2600	Change in the supplier of the reagent for immunization of rabbits and subsequent changes in manufacturing process and quality control procedures.
P000021/S008 7/11/05	Dimension tPSA Flex Reagent Cartridge	Dade Behring, Inc. Newark, DE 19714	Change to prevent loss of reagent due to microbial contamination.
P000033/S002 7/7/05	IntraCoil® Self-Expanding Peripheral Stent	Ev3, Inc. Plymouth, MN 55442	Change in the manufacturing process to the label printing and label verification process.
P000037/S006 7/11/05	On-X® Prosthetic Heart Valve	Medical Carbon Research Institute, LLC	Change in the cleaning methods used to remove manufacturing materials.
P010012/S048 7/7/05	Contak Renewal®	Guidant Corporation St. Paul, MN 55112	Removal of a manual audit of an incoming inspection process for IC wafers
P010012/S049 7/21/05	Contak CD CRT-D Models H115, H119 and Contak Renewal CRT-D Models H120, H125	Guidant Corporation St. Paul, MN 55112	Change in the set screw preload verification process.
P010012/S050 7/21/05	Contak Renewal, Contak Renewal 3 RF	Guidant Corporation St. Paul, MN 55112	Removal of a second cycle of electrical testing for capacitors.
P010012/S051 7/22/05	VENTAK family of Implantable Cardioverter Defibrillators	Guidant Corporation St. Paul, MN 55112	Alternate supplier of the Trim Resistor Arrays used in the hybrid builds of the PULSAR MAX, VENTAK and CONTAK CD families of devices.
P010012/S052 7/8/05	CONTAK CD, CONTAK RENEWAL, EASYTRAK	Guidant Corporation St. Paul, MN 55112	Changes in procedures for cytotoxicity and pyrogenicity testing for inspections of incoming components.
P010012/S053 7/27/05	Contak CD 2, Contak Renewal 3 DS, Contak Renewal 3 HE	Guidant Corporation St. Paul, MN 55112	Changes to the software used in the automated setscrew preload verification process.
P020027/S004 7/13/05	Dimension® FPSA Flex® Reagent Cartridge	Dade Behring, Inc. Newark, DE 19714	Change to prevent loss of reagent due to microbial contamination.
P030005/S009 7/21/05	Vitality AVT ICDs Models A135, A155	Guidant Corporation St. Paul, MN 55112	Change in the set screw preload verification process.
P030005/S010 7/8/05	CONTAK RENEWAL TR	Guidant Corporation St. Paul, MN 55112	Changes in procedures for cytotoxicity and pyrogenicity testing for inspections of incoming components.
P030026/S007 7/18/05	VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrators	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626	Change in the acceptance criteria for an initial manufacturing step.
P040024/S001 7/12/05	Restylane Injectable Gel	Medicis Scottsdale, AZ 85258	Changes to processing methods used in the manufacturing of Restylane Injectable Gel.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 37

Summary of PMA Originals Under Review
Total Under Review: 85
Total Active: 36
Total On Hold: 49
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 272
Total Active: 140
Total On Hold: 132
Number Greater Than 180 Days: 5

Summary of All PMA Submissions Received
Originals: 5
Supplements: 72

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 37
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 116.2
FDA Time: 102.3 Days MFR Time: 13.9 Days

Updated October 12, 2005

horizonal rule

Center for Devices and Radiological Health / CDRH