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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 NumberS015
Date Received06/08/2012
Decision Date08/10/2012
Product Code LOZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE PRESSURE LIMIT RANGE FOR THE EXTERNAL AIR PRESSURE REGULATOR OF THE DEVICE.
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