For Consumers

FDA-Approved Medical Devices for Cardiology and Vascular Diseases

The medical devices listed in this section include some of the newest medical technology available. The links 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.

For additional information about approved and cleared medical devices, see Device Approvals and Clearances

2012

Product	Manufacturer	Category	Approval Date
Omnilink Elite Vascular Balloon- Expandable Stent System	Abbott Vascular	Stent	7/31/2012
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)	Boston Scientific Corporation	Stent	6/1/2012
Epic™ Vascular Self-Expanding Stent System	Boston Scientific Corporation	Stent	4/13/2012
Presillion plus CoCr Coronary Stent on RX System	Medinol Ltd	Stent	4/12/2012
Medtronic CRDM Cardiac Resynchronization Therapy Defibrillators	Medtronic, Inc. Cardiac Rhythm Disease Management (CRDM)	Defibrillator	4/4/2012
Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent)	Cook Incorporated	Endovascular Graft	4/4/2012
EverFlex Self-Expanding Peripheral Stent System	ev3, Inc.	Stent	3/7/2012
TAXUS® Express2® Paclitaxel-Eluting Coronary Stent System (Monorail™ and Over-The-Wire Delivery Systems)	Boston Scientific Corporation	Stent	2/22/2012
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems)	Boston Scientific Corporation	Stent	2/22/2012
Absolute Pro® Vascular Self-Expanding Stent System	Abbott Vascular	Stent	2/22/2012
ION™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems)	Boston Scientific Corporation	Stent	2/22/2012
Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System and Resolute Integrity Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular, Inc	Stent	2/17/2012
GORE TAG Thoracic Endoprosthesis	W.L. Gore & Associates, Inc.	Endovascular Stent	1/13/2012

2011

Product	Manufacturer	Category	Approval Date
EXCOR® Pediatric Ventricular Assist Device (VAD)	Berlin Heart, GmbH	Ventricular Assist Device	12/16/2011
Edwards SAPIEN Transcatheter Heart Valve (THV) - P100041	Edwards Lifesciences	Heart valve	11/2/2011
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System - P110019	Abbott Vascular	Stent	11/1/2011
Assurant® Cobalt Iliac Balloon-Expandable Stent System - P110011	Medtronic Vascular	Stent	10/26/2011
XIENCE nano™ Everolimus Eluting Coronary Stent System - P070015/S054	Abbott Vascular	Stent	5/24/2011
RX Acculink Carotid Stent System - P040012/S034	Abbott Vascular	Stents	5/6/2011
ION™ Paclitaxel-Eluting Coronary Stent System - P100023	Boston Scientific Corporation	Stents	4/22/2011
St. Jude Medical® Trifecta™ Valve – P100029	St. Jude Medical	Heart valve	4/20/2011
Revo MRI SureScan Pacing System - P090013	Medtronic, Inc	Pacing	2/8/2011
Formula Balloon-Expandable Renal Stent System - P100028	Cook, Inc.	Stents	1/14/2011

2010

Product	Manufacturer	Category	Approval Date
Bard LifeStent and LifeStent XL Vascular Stent - P070014/S010	Bard Peripheral Vascular, Inc.	Stent	12/23/2010
Endurant Stent Graft System - P100021	Medtronic Vascular	Stent	12/16/2010
Boston Scientific Cardiac Resynchronization Therapy Defibrillators - P010012/S230	Boston Scientific	Defibillator	9/16/2010
Medtronic Vascular Complete® SE Vascular Stent System - P090006	Medtronic Vascular	Stent	3/17/2010
Express® LD Iliac Premounted Stent System - P090003	Boston Scientific Corporation	Stent	3/5/2010
Medtronic Melody® Transcatheter Pulmonary Valve - H080002	Medtronic Heart Valves, Inc.	Heart valve	1/25/2010

2009

Product	Manufacturer	Category	Approval Date
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	Boston Scientific Corporation	Stent	7/13/2009
TAXUS® Liberté® Atom™ (2.25 mm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems) - P060008/S008	Boston Scientific Corporation	Stent	5/21/2009
Medtronic® Attain Ability™ Model 4196 Lead - P080006	Medtronic, Inc.	Pacemaker leads	4/7/2009
LifeStent FlexStar and FlexStar XL Vascular Stent - P070014	Bard Peripheral Vascular, Inc.	Stent	2/13/2009

2008

Product	Manufacturer	Category	Approval Date
Express® SD Renal Monorail® Premounted Stent System - P060006	Boston Scientific Corporation	Stent	12/11/2008
E-LUMINEXX Vascular Stent - P080007	Bard Peripheral Vascular, Inc.	Stent	12/4/2008
Carotid WALLSTENT® Monorail® Endoprosthesis – P050019	Boston Scientific Corporation	Stent	10/23/2008
XIENCE™ V Everolimus Eluting Coronary Stent on the Over-the-Wire (OTW) or Rapid Exchange (RX) Stent Delivery Systems - P070015	Abbott Vascular	Stent	7/2/2008
Medtronic® Attain StarFix™ Model 4195 Lead - P060039	Medtronic, Inc.	Pacemaker	6/13/2008
Talent™ Thoracic Stent Graft System - P070007	Medtronic Vascular	Stent	6/5/2008
Zenith® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System - P070016	William Cook Europe, ApS	Endovascular graft	5/21/2008
ELA Ovatio CRT-D System - P060027	ELA Medical, Inc.	Ventricular Assist Device	5/15/2008
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	Biotronik Inc.	Pacemaker	5/12/2008
Thoratec HeartMate II LVAS - P060040	Thoratec Corporation	Ventricular Assist Device	4/21/2008
Talent™ Abdominal Stent Graft System – P070027	Medtronic Vascular	Endovascular Graft	4/15/2008
CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159 - P010012/S037	Guidant Corporation	Implantable Cardioverter Defibrillator	3/13/2008
Endeavor® Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi Exchange II (MX2) Stent Delivery Systems - P060033	Medtronic Vascular	Stents	2/1/2008