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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 NameTOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
Classification Nameartificial heart
Generic Nameimplantable total artificial heart
ApplicantSYNCARDIA SYSTEMS, INC.
PMA NumberP030011
Supplement NumberS009
Date Received11/22/2010
Decision Date01/04/2011
Product Code
LOZ[ Registered Establishments with LOZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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