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Medical Devices

2008 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2008. The products in each list 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 2008

2008 Device Approvals

Device NameCategoryDate
Express® SD Renal Monorail® Premounted Stent System - P060006 [ARCHIVED] Stent 12/11/08
BD FocalPoint™ GS Imaging System - P950009/S008 [ARCHIVED] Imaging System 12/03/08
E-LUMINEXX Vascular Stent - P080007 [ARCHIVED] Stent 12/04/08
BIOFINITY® (comfilcon A) Soft Contact Lens for Extended Wear - P080011 [ARCHIVED] Contact Lenses 11/19/08
COBAS TaqMan HCV Test For Use With the COBAS AmpliPrep Instrument and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer - P060030 [ARCHIVED] Hepatitis Test 10/30/08
Carotid WALLSTENT® Monorail® Endoprosthesis – P050019 [ARCHIVED] Stent 10/23/08
Helios II Ablation Catheter– P050029 [ARCHIVED] Ablation Catheters 10/08/08
Hoya iSpheric™ Model YA-60BB Intraocular Lens - P080004 [ARCHIVED] Intraocular Lens (IOL) 09/26/08
Akreos® Posterior Chamber Intraocular Lens - P060022 [ARCHIVED] Intraocular Lens (IOL) 09/05/08
COBAS TaqMan HBV Test For Use With The High Pure System - P050028 [ARCHIVED] Hepatitis Test 09/04/08
T-SPOT®.TB - P070006 [ARCHIVED] Tuberculosis Test 07/25/08
XIENCE™ V Everolimus Eluting Coronary Stent on the Over-the-Wire (OTW) or Rapid Exchange (RX) Stent Delivery Systems - P070015 [ARCHIVED] Stent 07/02/08
Invitrogen SPOT-Light® HER2 CISH™ Kit - P050040 [ARCHIVED] Breast Cancer Test 07/01/08
EVOLENCE® Collagen Filler - P070013 [ARCHIVED] Wrinkle Filler 06/27/08
Medtronic® Attain StarFix™ Model 4195 Lead - P060039 [ARCHIVED] Pacemaker 06/13/08
Talent™ Thoracic Stent Graft System - P070007 [ARCHIVED] Stent 06/05/08
Zenith® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System - P070016 [ARCHIVED] Endovascular Graft 05/21/08
ELA Ovatio CRT-D System - P060027 [ARCHIVED] Ventricular Assist Device 05/15/08
BIOTRONIK’s Stratos LV and Stratos LV T Cardiac Resynchronization Therapy Pacemakers and Corox OTW BP and Corox OTW S BP Left Ventricular Pacing Leads - P070008 [ARCHIVED] Pacemaker 05/12/08
Thoratec HeartMate II LVAS - P060040 [ARCHIVED] Ventricular Assist Device 04/21/08
Talent™ Abdominal Stent Graft System – P070027 [ARCHIVED] Endovascular Graft 04/15/08
CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159 - P010012/S037 [ARCHIVED] Implantable Cardioverter Defibrillator 03/13/08
FreeStyle Navigator® Continuous Glucose Monitoring System - P050020 [ARCHIVED] Glucose Monitor 03/12/08
Endeavor® Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi Exchange II (MX2) Stent Delivery Systems - P060033 [ARCHIVED] Stents 02/01/08
Dako TOP2A FISH pharmDx™ Kit - P050045 [ARCHIVED] Breast Cancer Test 01/11/08
xTAG™ Respiratory Viral Panel (RVP) - K063765 [ARCHIVED] Respiratory Virus Test 01/03/08

Page Last Updated: 09/05/2013
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