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Medical Devices

2009 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 2009

2009 Device Approvals

Device NameCategoryDate
DuraSeal Spine Sealant System - P030042 [ARCHIVED] Artificial Hip 11/03/09
VIDAS fPSA rt Assay - P080008 [ARCHIVED] PSA Test 10/08/09
DuraSeal Spine Sealant System - P080013 [ARCHIVED] Spine 09/04/09
Sculptra Aesthetic - P030050/S002 [ARCHIVED] Wrinkles 07/28/09
TAXUS® Liberte™ Long (2.75–4.00 mm x 38 mm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems) - P060008/S011 [ARCHIVED] Stent 07/13/09
Scandinavian Total Ankle Replacement System (STAR Ankle) - P050050 [ARCHIVED] Ankle Replacement 05/27/09
TAXUS® Liberté® Atom™ (2.25 mm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems) - P060008/S008 [ARCHIVED] Stent 05/21/09
BRYAN® Cervical Disc - P060023 [ARCHIVED] Cervical Disc 05/12/09
REPEL-CV Bioresorbable Adhesion Barrier - P070005 [ARCHIVED] Adhesion Barrier 03/06/09
ARCHITECT® CORE Reagent Kit, Calibrator and Controls - P080023 [ARCHIVED] HBV Test 04/10/09
Medtronic® Attain Ability™ Model 4196 Lead - P080006 [ARCHIVED] Pacemaker Leads 04/07/09
Cervista™ HPV 16/18 - P080015 [ARCHIVED] HPV Test Kit 03/12/09
CervistaTM HPV HR and GenfindTM DNA Extraction Kit - P080014 [ARCHIVED] HPV Test Kit 03/12/09
FC2 Female Condom - P080002 [ARCHIVED] Condom 03/10/09
Synvisc-One (hylan GF-20) - P940015/S012 [ARCHIVED] Osteoarthritis treatment 02/26/09
Reclaim™ DBS™ Therapy for OCD - H050003 [ARCHIVED] Brain Stimulator 02/19/09
LifeStent FlexStar and FlexStar XL Vascular Stent - P070014 [ARCHIVED] Stent 02/13/09
NAVISTAR® THERMOCOOL® and EZ Steer THERMOCOOL® Nav Irrigated Deflectable Diagnostic/Ablation Catheter for Treatment of Paroxysmal Atrial Fibrillation - P030031S011 [ARCHIVED] Catheter 02/06/09
XACT® Soft Acrylic UV Light-Absorbing Posterior Chamber Intraocular Lens - P080021 [ARCHIVED] Intraocular Lens 02/02/09
TECNIS® Multifocal Foldable Silicone and Acrylic Intraocular Lenses - P080010 [ARCHIVED] Intraocular Lens (IOL) 01/16/09

Page Last Updated: 09/06/2013
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