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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHORETEC HEARTMATE XVE LVAS
Generic NameVentricular (assist) bypass
ApplicantTHORATEC CORP.
6035 STONERIDGE DR.
PLEASANTON, CA 94588
PMA NumberP920014
Supplement NumberS017
Date Received11/12/2002
Decision Date04/04/2003
Withdrawal Date 10/03/2014
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN EXPANDED INDICATION FOR USE FOR THE THORATEC HEARTMATE XVE LVAS. THIS DEVICE SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE. IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION CLASS IV END STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 60 OF THE LAST 90 DAYS, AND WHO HAVE A LIFE EXPECTANCY OF LESS THAN TWO YEARS, AND WHO ARE NOT ELIGIBLE FOR CARDIAC TRANSPLANTATION. THE DEVICE SYSTEM IS APPROVED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.
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