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 for August 2004. 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
|
9/21/05 |
Total Temporomandibular Joint Replacement System |
Walter Lorenz Surgical, Inc. Jacksonville, FL 32218 |
Approval for the Total Temporomandibular Joint Replacement System. The device is indicated for reconstruction of the temporomandibular joint. The reconstruction is necessary due to one of the following diagnoses: 1) arthritic conditions: osteoarthritis, traumatic arthritis, rheumatoid arthritis, 2) ankylosis including but not limited to recurrent ankylosis with excessive heterotopic bone formation, 3) revision procedures where other treatments have failed (e.g. alloplastic reconstruction, autogenous grafts), 4) avascular necrosis, 5) multiply operated joints, 6) fracture, 7) functional deformity, 8) benign neoplasms, 9) malignancy (e.g. post-tumor excision), 10) degenerated or resorbed joints with severe anatomic discrepancies, and 11) developmental abnormality. |
|
9/6/05 |
Xact® Carotid Stent System |
Abbott Vascular Devices Redwood City, CA 94063 |
Approval for the Xact® Carotid Stent System. The Xact® Carotid Stent System, used in conjunction with the Abbott Vascular Devices embolic protection system, is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the criteria outlined as follows: 1) Patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography), located between the origin of the common carotid artery and the intra-cranial segment of the internal carotid artery; and 2) Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion |
PMA Supplemental Approvals
P790002/S023 9/26/05 Real-Time |
EBI Bone Healing System |
EBI, L.P. Parsippany, NJ 07054 |
Approval for three new coils: the FLX 5, the XL Coilette and the Mini Coilette and a modified version of the Bone Healing System Model 2001 controller. The device, as modified, will be marketed under the trade name EBI bone Healing System and is indicated for the treatment of fracture non-unions, failed fusions, and congenital pseudoarthroses in the appendicular system. |
P830055/S090 9/26/05 Real-Time |
LCS Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval to: change the name of the LCS Complete M1 PS femoral component to the LCS Complete RPS femoral component, add new sizes along with some minor design changes to the RPS femoral components, change the name of the LCS Complete M1 PS tibial bearing component to the LCS Complete RPS tibial bearing component, add new bearing thicknesses to the RPS tibial bearing components, and make dimensional changes to the tibial reinforcement pin used with the RPS tibial bearings; change the cam and spine mechanisms for the LCS Complete Revision femoral and tibial bearing components, add a medium size to the LCS Complete Revision femoral and tibial bearing components, change the name of the LCS Complete Revision tibial bearing component from VVC1 to VVC, and modify the tibial reinforcement pin used with the VVC tibial bearings. |
P830055/S091 9/12/05 Special |
LCS® Total Knee System – MBT Revision Cemented Tibial Trays; 1294-35-110, 1294-35-115, 1294-35-120, 1294-35-125, 1294-35-130, 1294-35-140, 1294-35-150, 1294-35-160, 1294-35-170 |
DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for a change in the criteria used in the manufacture of the referenced components. This modification adds a step to the inspection procedure by utilizing a gage to aid in the inspection of the Spiralock tapped hole prior to tapping. |
P840001/S080 9/23/05 Real-Time |
Restore™ Rechargeable Neurostimulation System |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Model 37083, Single Quadpolar Extension Kit. |
P840064/S029 9/21/05 Real-Time |
Viscoat Ophthalmic Viscosurgical Device |
Alcon Laboratories Fort Worth, TX 76134 |
Approval for replacement of the material of the tip cap and stopper for latex-free rubber components. |
P860004/S070 9/26/05 180-Day |
SynchroMed II Implantable Infusion System |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Model 8832 Personal Therapy Manager (PTM), an accessory to the SynchroMed II Implantable Infusion System, indicated for the patient to activate delivery of physician programmed supplemental doses of preservative-free morphine sulfate sterile solution from the SynchroMed II pump for the treatment of chronic intractable pain. |
P890003/S086 9/28/05 180-Day |
Model 9986 Desktop/Baseline Operating System Software v1.4 (BOSS) for the CareLink Programmer and the Model 8190 Analyzer Software v6.0 for the Model 2290 Analyzer |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for “software enhancements” to the Model 9986 Desktop/Baseline Operating System Software (BOSS) for the CareLink Programmer and the Model 8190 Analyzer Software for the Model 2290 Analyzer. |
P890003/S088 9/21/05 Real-Time |
Medtronic Model 2030A BatteryCheck Monitor |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a firmware upgrade of the BatteryCheck Monitor which will improve telemetry communication with the implanted device. |
P900056/S083 9/27/05 180-Day |
Rotawire™ Guide Wire, a component of the Rotablator Rotational Angioplasty System |
Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Approval for a contract sterilization site located at Steris Isomedix Services, Inc. (formerly Cosmed Sterilization Group of New Jersey), South Plainfield, New Jersey. |
P910007/S015 9/13/05 Special |
ABBOTT IMx® Total PSA, ABBOTT AxSYM® Total PSA and ABBOTT ARCHITECT® Total PSA |
Abbott Laboratories Diagnostics Division Abbott Park, IL 60064 |
Approval for addition of a bias analysis study to the reagent package inserts. |
P910016/S014 9/26/05 180-Day |
Unicompartmental Device Configuration of the LCS® Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for changes to the post-approval study. |
P910077/S051 9/8/05 180-Day |
LATITUDE Patient Management System |
Guidant Corporation Cardiac Rhythm Management |
Approval for the LATITUDE Patient Management System including the Model 6482 LATITUDE Communicator v1.4 and the Supplemental Application Server (SAS) software v1.0.1 for use in monitoring patients implanted with a Contak Renewal 3 RF. |
|
9/14/05 Panel |
ACRYSOF Toric Posterior Chamber Intraocular Lens Models SA60T3, SA60T4 and SA60T5 |
Alcon Research Ltd. Fort Worth, TX 76134 |
Approval for the ACRYSOF® Toric Posterior Chamber Intraocular Lens Models SA60T3, SA60T4 and SA60T5. The devices are 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. |
P930016/S023 9/28/05 Real-Time |
STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan Wavefront® System |
VISX, Inc. Santa Clara, CA 95051 |
Approval for minor design and labeling changes included in WaveScan software, version 3.65. |
P930038/S044 9/2/05 Special |
Angio-Seal™ Vascular Closure Device |
St. Jude Medical, Inc. Daig Division Minnetonka, MN 55345 |
Approval for instructions for use/labeling changes. |
P950029/S024 9/2/05 Real-Time |
Symphony/ELA Rhapsody Pacemaker System and the Orchestra Programmer |
ELA Medical, Inc. Plymouth, MN 55441 |
Approval for the following software updates: 1) AAIsafeR RAM patch 2.3 for Symphony DR 2550 devices with ROM mask T3, 2) ROM mask T4 for Symphony DR 2550, Symphony SR 2250, ELA Rhapsody+ DR 2530, ELA Rhapsody DR 2510, and ELA Rhapsody SR 2210, 3) Elaview 1.30 UG2 application software for the Orchestra programmer. |
P950039/S015 9/28/05 180-Day |
ThinPrep 2000 System |
Cytyc Corporation Marlborough, MA 01752 |
Approval for additional claims to the current approved labeling for ThinPrep 2000 System regarding removal of a 4 mL aliquot from the PreservCyt vial prior to preparation of the ThinPrep Pap test(TPPT). This aliquot is only to be used to support performance of ancillary tests approved by the FDA on PreservCyt material. |
P960011/S010 9/15/05 180-Day |
BioLon™ 1% Sodium Hyaluronate for Ophthalmic Surgery |
Savient Pharmaceuticals, Inc. East Brunswick, NJ 08816 |
Approval to include IOLTECH, Cidra, Puerto Rico as a distributor for Biolon in the United States. |
P960040/S072 9/22/05 Real-Time |
VITAITY HE Models T180 & T182, and VENTAK PRIZM 2 VR Model 1860 AICDs |
Guidant Corporation 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. |
P960058/S042 9/21/05 180-Day |
HiResolution™ Bionic Ear System |
Advanced Bionics Sylmar, CA 91342 |
Approval for a manufacturing site for receiving, receiving inspection, staging, packaging finished goods, and shipping located at Advanced Bionics, Sylmar, California. |
P970003/S058 9/29/05 Special |
VNS Therapy System- Model 302 Lead Physician’s Manual |
Cyberonics Houston, TX 77058 |
Approval for changes to the Model 302 Lead Physician’s Manual clarifying information regarding handling to avoid damage to the lead and helical electrodes. |
P970018/S010 9/28/05 Real-Time |
PrepStain™ System |
Tripath Imaging Durham, NC 27703 |
Approval for modification to the SurePath Slide preparation. |
P980016/S052 9/30/05 135-Day |
EnTrust Implantable Cardioverter Defibrillator (ICD) |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval to verify additional programming parameters at the post-sterilization manufacturing step. The devices, as modified, will be marketed under the trade names EnTrust Implantable Cardioverter Defibrillator and EnRhythm Implantable Pulse Generator respectively. |
P980016/S054 9/21/05 Real-Time |
Medtronic Model 2030A BatteryCheck Monitor |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a firmware upgrade of the BatteryCheck Monitor which will improve telemetry communication with the implanted device. |
P980035/S045 9/30/05 135-Day |
EnRhythm Implantable Pulse Generator (IPG) |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval to verify additional programming parameters at the post-sterilization manufacturing step. The devices, as modified, will be marketed under the trade names EnTrust Implantable Cardioverter Defibrillator and EnRhythm Implantable Pulse Generator respectively. |
P980035/S046 9/15/05 Real-Time |
EnPulse E1/E2 Implantable Pulse Generator Devices |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the use of an alternate package configuration and changes to the label stock. |
P980053/S008 9/26/05 180-Day |
Durasphere® Injectable Bulking Agent |
Carbon Medical Technologies, Inc. St. Paul, MN 55110 |
Approval for the 1 mL syringe used to deploy Durasphere Injectable Bulking Agent to be changed from a polycarbonate syringe with the latex-free compound tip to a syringe with a polypropylene silicone tip. |
P990001/S019 9/21/05 180-Day |
Vitatron T-Series Programming Software Model VSF07 Version 1.1; Vitatron T-Series Programming Software Model VSF08 Version 1.1; Vitatron VSE03 Version 2.2 CD-ROM; and Vitatron VSE04 Version 2.2 CD-ROM/ZIP-file |
Vitatron, Inc. Minneapolis, MN 55432 |
Approval for updated programming software, including the Ventricular Rate Stabilization feature, to be used with either the T60 DR Model T60A1 or T20 SR Model T20A1 devices. |
P990012/S002 9/22/05 135-Day |
Elecsys HBsAg Immunoassay, Elecsys HBsAg Confirmatory Test and Elecsys PreciControl HBsAg |
Roche Diagnostics Corporation Indianapolis, MN 46250 |
Approval for changes to the calibrator and control recovery ranges. |
P990020/S021 9/22/05 Special |
Medtronic Vascular AneuRx Stent Graft with Xcelerant Delivery System |
Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the addition of a new inspection test. |
P990037/S023 9/2/05 Special |
Duett ProSealing Device (Model 1010), Diagnostic Duett Pro Sealing Device (Model 2210), and D-Stat Flowable Hemostat (Model 4000) |
Vascular Solutions, Inc. Minneapolis, MN 55369 |
Approval to modify the procedure for determining acceptance of the Limulus Amebocyte Level (LAL) test results. |
P000032/S012 9/21/05 Real-Time |
Her Option™ Cryoablation Therapy System |
American Medical Systems Minnetonka, MN 55343 |
Approval for a change in material to the precool finned tubing and the mixed gas finned tubing from 304 stainless steel to Inconel 625 |
P000040/S006 9/21/05 Real-Time |
HTA™ System |
Boston Scientific Corporation Marlborough, MA 01752 |
Approval for the addition of the tenaculum stabilizer component to the HTA Procedure Set and for changes to the packaging, shelf-life and labeling associated with the addition of the component. |
P000046/S012 9/26/05 Special |
Staarvisc™ II Sodium Hyaluronate |
Anika Therapeutics, Inc. Woburn, MA 01801 |
Approval for the change in labeling to include cannula assembly instructions. |
P010031/S025 9/21/05 Real-Time |
Medtronic Model 2030A BatteryCheck Monitor |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a firmware upgrade of the BatteryCheck Monitor which will improve telemetry communication with the implanted device. |
P010039/S003 9/27/05 180-Day |
Siemens SONOCUR Basic Extracorporeal Shock Wave Therapy (ESWT) System |
Siemens Medical Solutions USA, Inc. Malvern, PA 19355 |
Approval for modifications to the post-approval protocol. |
P020004/S011 9/28/05 180-Day |
Gore EXCLUDER™ Bifurcated Endoprosthesis |
W.L. Gore & Associated, Inc. Flagstaff, AZ 86001 |
Approval for the addition of a shorter (12 cm) trunk/ipsilateral component to the Gore EXCLUDER™ Bifurcated Endoprosthesis product line. |
P020045/S010 9/2/05 Real-Time |
7F Freezor Cardiac CryoAblation Catheter & CCT.2 Cryoconsole System |
CryoCath Technologies, Inc. Kirkland, Quebec Canada H9H 5H3 |
Approval for a minor design change to the stop button on the CryoConsole from the current size of 19 mm to the proposed 16 mm size stop button. |
P030002/S004 9/8/05 Real-Time |
crystaLens SE™ (Model AT-45 SE) Multipiece Silicone Posterior Chamber Accommodating Intraocular Lens (IOL) |
Eyeonics, Inc. Aliso Viejo, CA 92656 |
Approval for the following modifications to the physician’s labeling: change in the model number and trade name; change in directions for use to facilitate proper insertion and orientation of the lens; and, change in the existing recommendations for maximizing patient outcomes. The device, as modified, will be marketed under the trade name crystaLens SE™ (Model AT-45 SE) and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. The crystaLens SE™ (Model AT-45 SE) provides approximately one diopter of monocular accommodation which allows for near, intermediate, and distance vision without spectacles. |
P030002/S005 9/26/05 Special |
crystaLens (Model AT045) Multipiece Silicone Posterior Chamber Accommodating Intraocular Lens (IOL) |
C & C Vision Aliso Viejo, CA 92656 |
Approval for changes in the “Recommendations for Maximizing Patient Outcomes” section of the physicians labeling. |
P030007/S001 9/16/05 Real-Time |
Kodak Mammography CAD Engine |
Eastman Kodak Company Rochester, NY 14650 |
Approval for minor updated to the computer-assisted detection algorithms. |
P030017/S017 9/16/05 180-Day |
Precision® Spinal Cord Stimulation System |
Advanced Bionics |
Approval for a manufacturing site for receiving, receiving inspection, staging, packaging, finished goods, and shipping located at Advanced Bionics, Sylmar, California. |
P040030/S001 9/29/05 Real-Time |
InSite™ HER-2/neu (CB11) Monoclonal Antibody |
BioGenex Laboratories, Inc. San Ramon, CA 94583 |
Approval for modification of the package insert of the InSite™ HER-2/neu kit, for use in the antibody-only version of the device. The device, as modified, will be marketed under the trade name InSite™ HER-2/neu (CB11) Monoclonal Antibody and is indicated for: InSite™ HER-2/neu (CB11) is a mouse monoclonal antibody that is intended for in vitro diagnostic use in Immunohistochemistry (IHC) assays to semi-quantitatively localize by light microscopy the over-expression of HER-2/neu (i.e., c-erB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue sections. InSite™ HER-2/neu (CB11) is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) therapy is being considered. Clinical interpretation of InSite™ HER-2/neu (CB11) immunostaining results (absence or presence; semi-quantitative intensity Score) should be complemented by appropriate controls and morphological tissue analysis and be evaluated by a qualified pathologist within the context of patient clinical history and other diagnostic results. |
30-Day Notices (135 Day Supplement was not required)
P870038/S007 9/13/05 |
Starr Edwards Silastic Ball Valve models 1260 and 6120 |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for a change in supplier of the PTFE monofilament sewing thread from W.L. Gore to Lenzing AG. |
P910073/S054 9/23/05 |
ENDOTAK RELAIANCE leads |
Guidant Corporation St. Paul, MN 55112 |
Change in the manufacturing process that adds a drug collar inspection to the assembly and bonding manufacturing instruction for the leads. |
P940031/S039 9/7/05 |
Guidant DISCOVERY, MERIDIAN Pulse Generators |
Guidant Corporation St. Paul, MN 55112 |
Upgrade the torque setscrew system software from v2.0 to v3.0. |
P940031/S040 9/7/05 |
Guidant DISCOVERY, MERIDIAN Pulse Generators |
Guidant Corporation St. Paul, MN 55112 |
Implementation of a die screen inspection and addition of a cratering failure mode for this inspection. |
P940031/S042 9/13/05 |
DISCOVERY/ MERIDIAN families |
Guidant Corporation St. Paul, MN 55112 |
Addition of an inline temperature and humidity controlled cure tunnel to fill channels. |
P940031/S043 9/27/05 |
DISCOVERY/ MERIDIAN Family |
Guidant Corporation St. Paul, MN 55112 |
Modification in the pin gauge tool. |
P950022/S026 9/13/05 |
Epic and Atlas families of devices |
St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 01342 |
Removal of a 14-day hold period by instituting Total and Delta Battery Current tests. |
P960040/S069 9/21/05 |
VITALITY Family of Implantable Cardioverter Defibrillators |
Guidant Corporation St. Paul, MN 55112 |
Addition of an Automated Vision System (equipment) to the inspection process for inspection of headers that will replace the manual visual inspection process to the family of CRT and ICD devices. |
P960040/S070 9/7/05 |
Guidant VITALITY family of Implantable Cardioverter Defibrillators and VENTAK PRIZM 2 Automatic implantable Cardioverter Defibrillators AICD |
Guidant Corporation St. Paul, MN 55112 |
Upgrade the torque setscrew system software from v2.0 to v3.0. |
P960040/S073 9/7/05 |
Guidant VITALITY family of Implantable Cardioverter Defibrillators |
Guidant Corporation St. Paul, MN 55112 |
Change in the method of attaching the header to the can involving roughening the area of attachment to improve bond strength. |
P960040/S074 9/7/05 |
Guidant VITALITY family of Implantable Cardioverter Defibrillators |
Guidant Corporation St. Paul, MN 55112 |
Implementation of a die screen inspection and addition of a cratering failure mode for this inspection. |
P960040/S076 9/13/05 |
VITALITY/PRIZM families |
Guidant Corporation St. Paul, MN 55112 |
Addition of an inline temperature and humidity controlled cure tunnel to fill channels. |
P960040/S077 9/8/05 |
VENTAK PRIZM 2DV/VR Pulse Generator Models 1860, 1861 |
Guidant Corporation St. Paul, MN 55112 |
Addition of a hybrid inspection step for lifted or cracked pads during the rework process. |
P960040/S079 9/15/05 |
VITALITY family |
Guidant Corporation St. Paul, MN 55112 |
Test modifications for the high voltage power modules in the VITALITY and RENEWAL DS ICDs. |
P960040/S080 9/15/05 |
Prizm 2 |
Guidant Corporation St. Paul, MN 55112 |
Change to the Lifted Positive DF (DF+) Pad inspection process. |
P960040/S082 9/23/05 |
VITALITY family of Defibrillators |
Guidant Corporation St. Paul, MN 55112 |
Change in the manufacturing process eliminating Vaccuum Bake and Inspection and the First Shelf Test step. |
P960040/S085 9/27/05 |
PRIZM/ VITALITY Family |
Guidant Corporation St. Paul, MN 55112 |
Modification in the pin gauge tool. |
D970003/S041 9/7/05 |
Guidant DISCOVERY, INSIGNIA, INTELLIS II, NEXUS, PULSAR Pulse Generators |
Guidant Corporation St. Paul, MN 55112 |
Upgrade the torque setscrew system software from v2.0 to v3.0. |
D970003/S042 9/7/05 |
INSIGNIA and NEXUS families |
Guidant Corporation St. Paul, MN 55112 |
Add a support fixture to the bonding process of the header and case. |
D970003/S043 9/7/05 |
INSIGNIA and NEXUS families |
Guidant Corporation St. Paul, MN 55112 |
Automation of the process of applying the medical adhesive to the device header and affixing the header to the device case. |
D970003/S044 9/7/05 |
PULSAR Max family of Implantable Pacemakers |
Guidant Corporation St. Paul, MN 55112 |
Change in the method of attaching the header to the can involving roughening the area of attachment to improve bond strength. |
D970003/S046 9/7/05 |
Guidant DISCOVERY, INSIGNIA, INTELLIS II, NEXUS, PULSAR Pulse Generators |
Guidant Corporation St. Paul, MN 55112 |
Implementation of a die screen inspection and addition of a cratering failure mode for this inspection. |
D970003/S047 9/13/05 |
DISCOVERY/ INSIGNIA/ PULSAR/NEXUS/ INTELIS families |
Guidant Corporation St. Paul, MN 55112 |
Addition of an inline temperature and humidity controlled cure tunnel to fill channels. |
D970003/S048 9/27/05 |
DISCOVERY/PULSAR MAX/INSIGNIA/NEXUS/INTELLIS Family |
Guidant Corporation St. Paul, MN 55112 |
Modification in the pin gauge tool. |
D970012/S027 9/1/05 |
Inflatable Penile Prosthesis Model 700 |
American Medical Systems Minnetonka, MN 55343 |
Change an in-process quality control monitoring step for endotoxin testing to a different location in the process flow. |
P000039/S007 9/16/05 |
AMPLATZER Duct Occluder |
AGA Medical Corporation Golden Valley, MN 55427 |
Alternate trimming method of the Nitinol wire braids. |
P000044/S008 9/22/05 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrators |
Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Change in supplier for the manufacture of a component used in the manufacture of the VITROS HBsAg Calibrator by Ortho-Clinical Diagnostics. |
P010012/S061 9/21/05 |
CONTAK RENEWAL 3 & 4 Family of Cardiac Resynchronization Therapy (CRT) Devices |
Guidant Corporation St. Paul, MN |
Addition of an Automated Vision System (equipment) to the inspection process for inspection of headers that will replace the manual visual inspection process to the family of CRT and ICD devices. |
P010012/S062 9/7/05 |
Guidant CONTAK RENEWAL family of Cardiac Resynchronization Therapy Devices |
Guidant Corporation St. Paul, MN 55112 |
Upgrade the torque setscrew system software from v2.0 to v3.0. |
P010012/S064 9/7/05 |
Guidant CONTAK RENEWAL family of Cardiac Resynchronization Therapy Devices |
Guidant Corporation St. Paul, MN 55112 |
Change in the method of attaching the header to the can involving roughening the area of attachment to improve bond strength. |
P010012/S065 9/7/05 |
Guidant CONTAK RENEWAL family of Cardiac Resynchronization Therapy Devices |
Guidant Corporation St. Paul, MN 55112 |
Implementation of a die screen inspection and addition of a cratering failure mode for this inspection. |
P010012/S067 9/13/05 |
CONTAK RENEWAL/CD 2/RENEWAL RF families |
Guidant Corporation St. Paul, MN 55112 |
Addition of an inline temperature and humidity controlled cure tunnel to fill channels. |
P010012/S068 9/15/05 |
RENEWAL DS family |
Guidant Corporation St. Paul, MN 55112 |
Test modifications for the high voltage power modules in the VITALITY and RENEWAL DS ICDs. |
P010012/S070 9/15/05 |
CONTAK RENEWAL 3 |
Guidant Corporation St. Paul, MN 55112 |
Change to the Lifted Positive DF (DF+) Pad inspection process. |
P010012/S072 9/23/05 |
CONTAK RENEWAL family of Defibrillators |
Guidant Corporation St. Paul, MN 55112 |
Change in the manufacturing process eliminating Vaccuum Bake and Inspection and the First Shelf Test step. |
P010012/S073 9/27/05 |
CONTAK RENEWAL Family |
Guidant Corporation St. Paul, MN 55112 |
Modification in the pin gauge tool. |
P010018/S008 9/30/05 |
Viewpoint® CK System |
Refractec, Inc. Irvine, CA 92618 |
Implementation of a controlled adhesive application process to more accurately control the amount of adhesive applied. |
P020024/S002 9/16/05 |
AMPLATZER Duct Occluder |
AGA Medical Corporation Golden Valley, MN 55427 |
Alternate trimming method of the Nitinol wire braids. |
P030005/S011 9/9/05 |
CONTAK RENEWAL TR family |
Guidant Corporation St. Paul, MN 55112 |
Adding a second supplier, MicroCrystal, for the piezoelectric quartz crystal component used in the CONTAK RENEWAL TR devices. |
P030005/S012 9/7/05 |
CONTAK RENEWAL TR family |
Guidant Corporation St. Paul, MN 55112 |
Add a support fixture to the bonding process of the header and case. |
P030005/S013 9/7/05 |
CONTAK RENEWAL TR IS-1 family |
Guidant Corporation St. Paul, MN 55112 |
Automation of the process of applying the medical adhesive to the device header and affixing the header to the device case. |
P030005/S014 9/13/05 |
CONTAK RENEWAL TR Models H120 and H125 |
Guidant Corporation St. Paul, MN 55112 |
Updated inspection criteria for bubbles within the medical adhesive in the header assembly. |
P030005/S015 9/8/05 |
CONTAK RENEWAL TR Models H120 and H125 |
Guidant Corporation St. Paul, MN 55112 |
Changes made to the software of the Automated Setscrew Preload system for the models listed that were inadvertently left ou of a previous 30-day notice. |
P030005/S016 9/13/05 |
CONTAK RENEWAL TR family |
Guidant Corporation St. Paul, MN 55112 |
Addition of an inline temperature and humidity controlled cure tunnel to fill channels. |
P030005/S018 9/27/05 |
CONTAK RENEWAL TR Family |
Guidant Corporation St. Paul, MN 55112 |
Modification in the pin gauge tool. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 43
Summary of PMA Originals Under Review
Total Under Review: 90
Total Active: 35
Total On Hold: 55
Number Greater Than 180 Days: 2
Summary of PMA Supplements Under Review
Total Under Review: 320
Total Active: 155
Total On Hold: 165
Number Greater Than 180 Days: 4
Summary of All PMA Submissions Received
Originals: 6
Supplements: 84
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 43
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 87.9
FDA Time: 75.0 Days MFR Time: 12.9 Days
Updated March 29, 2007
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Center for Devices and Radiological Health / CDRH
