The products listed on this page include some of the newest medical technology available. Each product listing contains 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. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/MDA/mda-list.cfm?list=1 en-us Thu, 24 Jul 2008 04:56:59 GMT webo@cdrh.fda.gov http://www.fda.gov/cdrh/images/homepg/c-d-r-h.gif http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/MDA/mda-list.cfm?list=1 The Medtronic ® Attain StarFix™ Model 4195 Lead is a surgically implanted insulated wire that is designed to be used as a part of a biventricular pacemaker system. The 4195 lead is designed to be implanted in a branch of the coronary vein that goes over.. (Approved: 6/13/2008) Fri, 11 Jul 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P060039.html http://www.fda.gov/cdrh/mda/docs/P060039.html The XIENCE V Stent is a metal scaffold with the drug everolimus contained in a thin coating. The XIENCE V Stent is mounted on a folded balloon attached to a catheter delivery system, for placement into the coronary artery (blood vessel supplying blood... (Approved: 7/2/2008) Thu, 03 Jul 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P070015.html http://www.fda.gov/cdrh/mda/docs/P070015.html The Zenith® TX2 ® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. (Approved: 5/21/2008) Thu, 03 Jul 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P070016.html http://www.fda.gov/cdrh/mda/docs/P070016.html The Stratos LV (-T) Cardiac Resynchronization Therapy Pacemakers (CRT-P) are rate adaptive pulse generators that also provide Cardiac Resynchronization Therapy (CRT) for patients with heart failure. (Approved: 5/12/2008) Fri, 13 Jun 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P070008.html http://www.fda.gov/cdrh/mda/docs/P070008.html The Ovatio CRT-D System is used to help treat congestive heart failure, a condition where the heart can not adequately pump blood around the body. It does this by providing specially timed electrical impulses to simultaneously stimulate... (Approved: 5/15/2008) Tue, 10 Jun 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P060027.html http://www.fda.gov/cdrh/mda/docs/P060027.html The Talent™ Thoracic Stent Graft System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Thoracic Stent Graft System is made of a fabric tube... (Approved: 6/5/2008) Tue, 10 Jun 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P070007.html http://www.fda.gov/cdrh/mda/docs/P070007.html The HeartMate II LVAS is a left ventricular assist device (LVAD) system; a device that helps the heart?s left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. The HeartMate II LVAS includes... (Approved: 4/21/2008) Tue, 06 May 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/p060040.html http://www.fda.gov/cdrh/mda/docs/p060040.html The Talent™ Abdominal Stent Graft System is used to repair aneurysms of the aorta in the abdomen (belly). An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Abdominal Stent Graft System is made of a fabric... (Approved: 4/15/2008) Thu, 17 Apr 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P070027.html http://www.fda.gov/cdrh/mda/docs/P070027.html The CONTAK RENEWAL® 3 AVT CRT-D® is an implantable cardioverter defibrillator (ICD) that also delivers cardiac resynchronization therapy (CRT) and atrial therapies. (Approved: 3/13/2008) Fri, 11 Apr 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P010012S037.html http://www.fda.gov/cdrh/mda/docs/P010012S037.html (Approved: 1/11/2008) Fri, 28 Mar 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P050045.html http://www.fda.gov/cdrh/mda/docs/P050045.html The FreeStyle Navigator Glucose Monitoring System is a glucose sensor that reports glucose values continuously for up to 120 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, age 18 and... (Approved: 3/12/2008) Fri, 28 Mar 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P050020.html http://www.fda.gov/cdrh/mda/docs/P050020.html The Endeavor® Zotarolimus-Eluting Coronary Stent is a tiny, expandable, mesh-like tube made of a cobalt-based metal with a drug (called zotarolimus) contained within a thin polymer coating on its surface. The Stent is mounted over a deflated... (Approved: 2/1/2008) Tue, 12 Feb 2008 05:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P060033.html http://www.fda.gov/cdrh/mda/docs/P060033.html The xTAG™ Respiratory Viral Panel (RVP) assay is a new device that can simultaneously detect and identify nucleic acids of multiple respiratory viruses in nasopharyngeal swab specimens from individuals suspected of respiratory tract infections. Acute... (Approved: 1/3/2008) Mon, 11 Feb 2008 05:00:00 GMT http://www.fda.gov/cdrh/mda/docs/K063765.html http://www.fda.gov/cdrh/mda/docs/K063765.html