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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.
 
DeviceCARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
Generic NameArtificial heart
ApplicantSYNCARDIA SYSTEMS, LLC
1992 E. SILVERLAKE RD.
TUCSON, AZ 85713
PMA NumberP030011
Supplement NumberS006
Date Received11/23/2009
Decision Date12/23/2009
Product Code LOZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF A HEAT TREATMENT STEP.
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