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Medical Devices

2011 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2011. The products in each list contain information about what medical uses the device is cleared or 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 Cleared or Approved by FDA in 2011

Device NameCategoryDate
Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) - H100004 [ARCHIVED] VAD 12/16/11
AtriCure Synergy Ablation System - P100046 [ARCHIVED] Ablation Clamp 12/15/11
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the MODULAR ANALYTICS E170 Immunoassay Analyzer - P110025 [ARCHIVED] HBV Test 12/14/11
HER2 CISH pharmDx™ Kit - P100024 [ARCHIVED] Cancer Test 11/30/11
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System - P110010 [ARCHIVED] Stent 11/22/11
BSD-2000 Hyperthermia System - H090002 [ARCHIVED] Cervical Cancer 11/18/11
Belotero Balance - P090016 [ARCHIVED] Wrinkles 11/14/11
Edwards SAPIEN Transcatheter Heart Valve (THV) - P100041 [ARCHIVED] Heart Valve 11/02/11
OVATION Abdominal Stent Graft System - H100008 [ARCHIVED] Stent 11/01/11
MelaFind® - P090012 [ARCHIVED] Imaging 11/01/11
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System - P110019 [ARCHIVED] Stent 11/01/11
APTIMA® HPV Assay - P100042 [ARCHIVED] HPV Assay 10/28/11
Assurant® Cobalt Iliac Balloon-Expandable Stent System - P110011 [ARCHIVED] Stent 10/26/11
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM on the cobas e 601 analyzer - P110022 [ARCHIVED] Hepatitis B Virus (HBV) 10/26/11
Restylane® Injectable Gel - P040024/S051 [ARCHIVED] Wrinkle Filler 10/11/11
EUFLEXXA® - P010029/S008 [ARCHIVED] Osteoarthritis 10/11/11
ADVIA Centaur® HBeAg Assay and ADVIA Centaur® HBeAg Quality Control Material - P090024 [ARCHIVED] HBeAg Test 10/11/11
NeuRx Diaphragm Pacing System™ - H100006 [ARCHIVED] Diaphragm 09/28/11
LeGoo® - P110003 [ARCHIVED] Surgical 09/28/11
Vysis ALK Break Apart FISH Probe Kit, with the Vysis Paraffin Pretreatment IV and Post Hybridization Wash Buffer Kit, ProbeChek ALK Negative Control Slides, and ProbeChek ALK Positive Control Slides - P110012 [ARCHIVED] Genetic Test 08/26/11
cobas® 4800 BRAF V600 Mutation Test - P110020 [ARCHIVED] Molecular Assay 08/17/11
Propel - P100044 [ARCHIVED] Sinus Implant 08/11/11
RX Herculink Elite Renal Stent System - P110001 [ARCHIVED] Renal Stent 07/20/11
VITROS® Immunodiagnostic Products Anti-HBe Reagent Pack, Calibrator and Controls - P100001 [ARCHIVED] HBV test 07/20/11
Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc on the Elecsys® 2010 Immunoassay Analyzer – P100032 [ARCHIVED] HBV test 06/27/11
Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc for use on the E170 MODULAR ANALYTICS - P100031 [ARCHIVED] HBV test 06/22/11
INFORM HER2 Dual ISH DNA Probe Cocktail – P100027 [ARCHIVED] DNA Probe Cocktail 06/14/11
Pinnacle® CoMplete® Acetabular Hip System - P090002 [ARCHIVED] Hip Replacement 06/13/11
Solesta® - P100014 [ARCHIVED] Fecal Incontinence 05/27/11
XIENCE nano™ Everolimus Eluting Coronary Stent System - P070015/S054 [ARCHIVED] Stents 05/24/11
EXOSEAL Vascular Closure Device - P100013 [ARCHIVED] Vascular Plug 05/19/11
Abbott RealTime HCV – P100017 [ARCHIVED] Hepatitis C 05/17/11
VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls - P090028 [ARCHIVED] HBV test 05/11/11
RX Acculink Carotid Stent System - P040012/S034 [ARCHIVED] Stents 05/06/11
AcrySof® Toric Intraocular Lens - (IOL) - P930014/S045 [ARCHIVED] Intraocular Lens 05/03/11
ION™ Paclitaxel-Eluting Coronary Stent System - P100023 [ARCHIVED] Stents 04/22/11
St. Jude Medical® Trifecta™ Valve – P100029 [ARCHIVED] Heart Valve 04/20/11
cobas HPV Test – P100020 [ARCHIVED] HPV test 04/19/11
NovoTTF-100A System - P100034 [ARCHIVED] Tumor Treatment 04/08/11
Pipeline™ Embolization Device - P100018 [ARCHIVED] Aneurysms 04/06/11
cPAX Aneurysm Treatment System - H100002 [ARCHIVED] Aneurysms 04/01/11
Valiant® Thoracic Stent Graft with the Captivia Delivery System - P100040 [ARCHIVED] Aneurysms 04/01/11
MEL 80™ Excimer Laser System - P060004/S001 [ARCHIVED] LASIK 03/28/11
Gel-One® - P080020 [ARCHIVED] Osteoarthritis 03/22/11
Medtronic® InterStim® Therapy System - P080025 [ARCHIVED] Incontinence 03/14/11
Elana Surgical KitHUD - H080005 [ARCHIVED] Neurosurgery 03/10/11
OraQuick HCV Rapid Antibody Test - P080027/S001 [ARCHIVED] Hepatitis C 02/18/11
LAP-BAND® Adjustable Gastric Banding System - P000008/S017 [ARCHIVED] Gastric Band 02/16/11
Selenia Dimensions 3D System - P080003 [ARCHIVED] Mammography 02/11/11
Revo MRI SureScan Pacing System - P090013 [ARCHIVED] Pacing 02/08/11
Formula Balloon-Expandable Renal Stent System - P100028 [ARCHIVED] Stents 01/14/11

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