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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.
 
DeviceSYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
Generic NameArtificial heart
ApplicantSYNCARDIA SYSTEMS, LLC
1992 E. SILVERLAKE RD.
TUCSON, AZ 85713
PMA NumberP030011
Supplement NumberS007
Date Received01/15/2010
Decision Date04/28/2010
Product Code LOZ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00614510
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE TRADE NAME CHANGE OF THE SUBJECT DEVICE. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART AND IS INDICATED FOR USE IN TRANSPLANT-ELIGIBLE CANDIDATES IN IMMINENT DANGER OF DEATH FROM IRREVERSIBLE BIVENTRICULAR FAILURE.
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