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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 (TAH-T) SYSTEM
Generic NameArtificial heart
ApplicantSyncardia Systems, LLC
1992 E. Silverlake Rd.
Tucson, AZ 85713
PMA NumberP030011
Supplement NumberS011
Date Received06/10/2011
Decision Date05/16/2012
Product Code LOZ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00614510
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE COMPANION 2 DRIVER SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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