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Medical Devices

2004 Device Approvals

The products listed below contain information about what medical uses the device is approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

Medical Devices Approved by FDA in 2004

Device NameCategoryDate
ADVIA Centaur® HBc Total ReadyPack Reagents, ADVIA Centaur® HBc Total Quality Control Materials - P040004 [ARCHIVED] Hepatitis Test 12/27/04
Roche AmpliChip Cytochrome P450 Genotyping test and Affymetrix GeneChip Microarray Instrumentation System - K042259 [ARCHIVED] Genetic Test 12/23/04
ADVIA Centaur® HAV IgM - P040018 [ARCHIVED] Hepatitis Test 12/22/04
Bayer ADVIA® Centaur™ HCV Assay - P030056 [ARCHIVED] Hepatitis Test 12/22/04
InSite™ Her-2/neu kit - P040030 [ARCHIVED] Breast Cancer Test 12/22/04
Reflection® Ceramic Acetabular System [ARCHIVED] Hip Prostheses 12/17/04
GORE VIATORR® TIPS Endoprosthesis - P040027 [ARCHIVED] Stent 12/06/04
URYX® Urethral Bulking Agent - P030030 [ARCHIVED] Urinary Bulking Agent 12/16/04
Vysis® AutoVysion™ System - K041875 [ARCHIVED] Genetic Test 12/13/04
Nuflexxa™ (1 percent Sodium Hyaluronate) - P010029 [ARCHIVED] Arthritis Injection 12/03/04
Kodak Mammography CAD ENGINE - P030007 [ARCHIVED] Mammography 11/23/04
NAVISTAR™ and CELSIUS™ THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter - P030031 [ARCHIVED] Ablation Catheter 11/05/04
Hamilton Thorne Zona Infrared Laser Optical System (ZILOS-tk®) - K040045 [ARCHIVED] Laser 11/04/04
EVS™ Vascular Closure System - P040022 [ARCHIVED] Vascular Closure Device 11/03/04
Endologix PowerLink® System - P040002 [ARCHIVED] Vascular Graft 10/29/04
CHARITÉ™ Artificial Disc - P040006 [ARCHIVED] Spinal Disc 10/26/04
ExAblate® 2000 System - P040003 [ARCHIVED] Fibroid Treatment 10/22/04
Syncardia Temporary CardioWest Total Artificial Heart (TAH-t) - P030011 [ARCHIVED] Artificial Heart 10/15/04
JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - P040029 [ARCHIVED] Contact Lens 09/29/04
Philips HeartStart Home OTC Defibrillator - K040904 [ARCHIVED] Defibrillator 09/16/04
Guidant Cardiac Resynchronization Therapy Defibrillators (COMPANION trial) - P010012/S026 [ARCHIVED] Defibrillator 09/14/04
ADVIA Centaur® Anti-HBs ReadyPack Reagents and Calibrators - P030029 [ARCHIVED] Hepatitis Test 09/10/04
Verisyse™ Phakic IOL - P030028 [ARCHIVED] Intraocular Lens (IOL) 09/10/04
ACCULINK™ Carotid Stent System / RX ACCULINK™ Carotid Stent System - P040012 [ARCHIVED] Stent 08/30/04
NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970 - K031878 [ARCHIVED] Amino Acid Test 08/24/04
Vertical Expandable Prosthetic Titanium Rib (VEPTR) - H030009 [ARCHIVED] Prostheses 08/23/04
Siemens Mammomat Novation DR Full Field Digital Mammography System - PMA P030010 [ARCHIVED] Mammography 08/20/04
Ventana® Medical Systems' PATHWAY Anti-c-KIT (9.7) Primary Antibody [ARCHIVED] Rib Prosthesis 08/11/04
ADVIA Centaur® HBc IgM ReadyPack Reagents / ADVIA Centaur® HBc IgM Quality Control (Calibrator and Control) Materials - P030040 [ARCHIVED] Hepatitis Test 08/06/04
Sculptra - P030050 [ARCHIVED] Wrinkle Filler 08/03/04
CEDIA® Sirolimus Assay - K034069 [ARCHIVED] Lab Test 07/28/04
INTACS® Prescription Inserts for Keratoconus - H040002 [ARCHIVED] Corneal Insert 07/26/04
Stelid II, Stelix, and Stelix II steroid eluting endocardial pacing leads - P020030 [ARCHIVED] Pacemaker 07/17/04
bioMerieux VIDAS total PSA assay - P040008 [ARCHIVED] PSA Test 07/08/04
St. Jude Medical® Epic™ HF and Atlas® + HF Dual Chamber Implantable Cardioverter Defibrillator Systems with Cardiac Resynchronization Therapy - P030054 [ARCHIVED] Defibrillators 06/30/04
IntraStent® DoubleStrut™ Stent- P030045 [ARCHIVED] Stent 06/08/04
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - P010062 [ARCHIVED] Contact Lens 06/07/04
Glucatell™ - K032373 [ARCHIVED] Lab Test 05/21/04
St. Jude Medical Frontier™ Biventricular Cardiac Pacing System [ARCHIVED] Pacemaker 05/13/04
INFUSE® Bone Graft - P000054 [ARCHIVED] Bone Graft 04/30/04
Oculaid™ Capsular Tension Ring, or Stableyes™ Capsular Tension Ring - P030023 [ARCHIVED] Intraocular Lens (IOL) 04/27/04
PRECISION™ Spinal Cord Stimulator (SCS) System - P030017 [ARCHIVED] Spinal Stimulator 04/27/04
Hylaform - P030032 [ARCHIVED] Wrinkle Filler 04/22/04
Oxford™ Meniscal Unicompartmental Knee System - P010014 [ARCHIVED] Knee Prosthesis 04/21/04
OP-1 Putty - H020008 [ARCHIVED] Spinal Implant 04/07/04
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System - P030025 [ARCHIVED] Stent 03/04/04
Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator - P030026 [ARCHIVED] Hepatitis Test 04/03/04
Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator - P030024 [ARCHIVED] Hepatitis Test 03/04/04
DeBakey VAD® Child - H030003 [ARCHIVED] Ventricular Assist Device 02/25/04
Heartsbreath - H030004 [ARCHIVED] Lab Test 02/24/04
Prolieve™ - P030006 [ARCHIVED] Prostate Treatment 02/19/04
DakoCytomation EGFR pharmDx™ - P030044 [ARCHIVED] Lab Test 02/12/04
Abbott AxSYM® Antibody to Hepatitis C Virus - P970027 [ARCHIVED] Hepatitis Test 02/05/04
AxSYM Free PSA - P980007 [ARCHIVED] PSA Test 02/05/04
Orthovisc® High Molecular Weight Hyaluronan - P030019 [ARCHIVED] Arthritis Injection 02/04/04
CONTAK® RENEWAL™ TR Models H120 and H125 - P030005 [ARCHIVED] Pacemaker 01/26/04
CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer - K031588 [ARCHIVED] Breast Cancer Test 01/21/04

Page Last Updated: 09/04/2013
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