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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 NumberS093
Date Received06/20/2024
Decision Date11/19/2025
Product Code LOZ 
Advisory Committee Cardiovascular
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 addition of a cover to go over the CPC quick connector components between the Total Artificial Heart and the pneumatic drivers.
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