Medical Devices Cleared or Approved by FDA in 2012

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