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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.
 
DeviceTotal Artificial Heart
Generic NameArtificial heart
ApplicantSyncardia Systems, LLC
1992 E. Silverlake Rd.
Tucson, AZ 85713
PMA NumberP030011
Supplement NumberS081
Date Received08/10/2022
Decision Date06/25/2025
Product Code LOZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the protocol for the SynCardia 50cc temporary Total Artificial Heart (TAH-t) Post Approval Study.
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