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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
Classification Nameartificial heart
Generic Nameimplantable total artificial heart
ApplicantSYNCARDIA SYSTEMS, INC.
PMA NumberP030011
Supplement NumberS010
Date Received01/26/2011
Decision Date02/18/2011
Product Code
LOZ[ Registered Establishments with LOZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Relocation of several critical manufacturing operations from building to another within the same corporate complex.
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