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Medical Devices
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July 2005 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. 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. |
| P970003S050 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. |
| P980022S011 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
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