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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 NumberS074
Date Received10/28/2019
Decision Date11/26/2019
Product Code LOZ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to update labeling in the Freedom Driver System manuals and clinical training slides.
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