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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 NumberS007
Date Received01/15/2010
Decision Date04/28/2010
Product Code
LOZ[ Registered Establishments with LOZ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00614510
NCT00733447
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the trade name change of the subject device. The device will be marketed under the trade name syncardia temporary total artificial heart and is indicated for use in transplant-eligible candidates in imminent danger of death from irreversible biventricular failure.
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