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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 NameCARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
Classification Nameartificial heart
Generic Nameimplantable total artificial heart
ApplicantSYNCARDIA SYSTEMS, INC.
PMA NumberP030011
Supplement NumberS006
Date Received11/23/2009
Decision Date12/23/2009
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 
Addition of a heat treatment step.
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