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Medical Devices

2012 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2012. 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 2012

Device NameCategoryDate
MarginProbe System – P110014 [ARCHIVED] Diagnostic Probe 12/27/12
Abbott Laboratories ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls - P120008 [ARCHIVED] Lab Test 11/28/12
HeartWare Ventricular Assist System - P100047 [ARCHIVED] Implanted Heart Pump 11/20/12
Zilver® PTX® Drug-Eluting Peripheral Stent - P100022 [ARCHIVED] Stent 11/14/12
S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems - P120002 [ARCHIVED] Stent 11/07/12
Medtronic Valiant Thoracic Stent Graft with the Captivia Delivery System - P100040/S008 [ARCHIVED] Stent 10/26/12
PCM Cervical Disc System - P100012 [ARCHIVED] Cervical Disc 10/26/12
Edwards SAPIEN Transcatheter Heart Valve (THV) – P110021 [ARCHIVED] Transcatheter Heart Valve 10/19/12
Magnetic Resonance guided Focused Ultrasound Surgery System (MRgFUS), ExAblate Model 2000/2100 - P110039 [ARCHIVED] Ultrasound surgery 10/18/12
coflex Interlaminar Technology - P110008 [ARCHIVED] Interlaminar Device 10/17/12
APTIMA® HPV 16 18/45 Genotype Assay - P120007 [ARCHIVED] HPV Test 10/12/12
OVATION Abdominal Stent Graft System - P120006 [ARCHIVED] Stent 10/05/12
Dexcom G4 PLATINUM Continuous Glucose Monitoring System - P120005 [ARCHIVED] Glucose Monitor 10/05/12
Subcutaneous Implantable Defibrillator (S-ICD) System - P110042 [ARCHIVED] Defibrillator 09/28/12
SECURE®-C Artificial Cervical Disc – P100003 [ARCHIVED] Cervical Disc 09/28/12
Relay® Thoracic Stent-Graft with Plus Delivery System - P110038 [ARCHIVED] Stent 09/21/12
somo-v Automated Breast Ultrasound System (ABUS) - P110006 [ARCHIVED] Imaging 09/18/12
Restylane-L Injectable Gel - P040024/S056 [ARCHIVED] Wrinkle Fillers 08/30/12
Omnilink Elite Vascular Balloon-Expandable Stent System - P110043 [ARCHIVED] Stent 07/31/12
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer - P110031 [ARCHIVED] HBV Test 01/03/12
therascreen® KRAS RGQ PCR Kit - P110030 [ARCHIVED] Genetic Test 07/06/12
COBAS® AmpliPrep/COBAS® TaqMan® CMV Test - P110037 [ARCHIVED] CMV Test 07/05/12
Healon® EndoCoat Ophthalmic Viscosurgical Device (OVD) - P110007 [ARCHIVED] Eye 07/02/12
Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and Inserter (GTS-100i) - P080030 [ARCHIVED] Stent (Eye) 06/25/12
Access® Hybritech p2PSA on the Access Immunoassay Systems – P090026 [ARCHIVED] PSA Test 06/14/12
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) - P110010/S001 [ARCHIVED] Stent 06/01/12
Presillion plus CoCr Coronary Stent on RX System - P110004 [ARCHIVED] Stent 05/01/12
BOND™ ORACLE™ Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemical (IHC) System - P090015 [ARCHIVED] Breast Cancer Test 04/24/12
Epic™ Vascular Self-Expanding Stent System - P110035 [ARCHIVED] Stent 04/24/12
ARCHITECT HBsAg - P110029 [ARCHIVED] Reagents 04/12/12
Medtronic CRDM Cardiac Resynchronization Therapy Defibrillators - P010031/S232 [ARCHIVED] Defibrillator 04/04/12
Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent) - P020018/S040 [ARCHIVED] Endovascular Graft 04/04/12
LINX™ Reflux Management System - P100049 [ARCHIVED] GERD 03/22/12
Sientra Silicone Gel Breast Implants - P070004 [ARCHIVED] Breast Implants 03/09/12
EverFlex Self-Expanding Peripheral Stent System - P110023 [ARCHIVED] Stent 03/07/12
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems) - P060008/S046 [ARCHIVED] Stent 02/22/12
TAXUS® Express2® Paclitaxel-Eluting Coronary Stent System (Monorail™ and Over-The-Wire Delivery Systems) - P030025/S086 [ARCHIVED] Stent 02/22/12
ION™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems) - P100023/S015 [ARCHIVED] Stent 02/22/12
The BreathTek UBT H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0 - P100025 [ARCHIVED] H. pylori Test 02/22/12
Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) - P110013 [ARCHIVED] Stent 02/17/12
PROGENSA® PCA3 Assay - P100033 [ARCHIVED] Prostate Test 02/13/12
Breast Companion® Software System - P100007 [ARCHIVED] Imaging 02/10/12
Absolute Pro® Vascular Self-Expanding Stent System - P110028 [ARCHIVED] Stent 02/22/12
Prometra® Programmable Infusion Pump System - P080012 [ARCHIVED] Infusion Pump 02/07/12
Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™ Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator - P110016 [ARCHIVED] Ablation Catheter 01/25/12
M-Vu Algorithm Engine - P100005 [ARCHIVED] Mammography 01/23/12
ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA® Centaur and ADVIA® Centaur XP Systems - P100039 [ARCHIVED] HBV Test 01/20/12
GORE TAG Thoracic Endoprosthesis - P040043/S040 [ARCHIVED] Endovascular Stent 01/13/12

Page Last Updated: 01/17/2014
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