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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 NumberS020
Date Received02/15/2013
Decision Date06/26/2014
Product Code LOZ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00733447
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FREEDOM® DRIVER SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART WITH THE FREEDOM® DRIVER SYSTEM AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES WHO HAVE BEEN IMPLANTED WITH THE TAH-T AND ARE CLINICALLY STABLE.
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