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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
Classification Nameartificial heart
Generic Nameimplantable total artificial heart
ApplicantSYNCARDIA SYSTEMS, INC.
PMA NumberP030011
Supplement NumberS020
Date Received02/15/2013
Decision Date06/26/2014
Product Code
LOZ[ Registered Establishments with LOZ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00733447
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the freedom® driver system. The device, as modified, will be marketed under the trade name syncardia temporary total artificial heart with the freedom® driver system and is indicated for use as a bridge to transplantation in cardiac transplant candidates who have been implanted with the tah-t and are clinically stable.
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