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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
Classification Nameartificial heart
Generic Nameartificial heart
Applicant
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake rd.
tucson, AZ 85713
PMA NumberP030011
Supplement NumberS011
Date Received06/10/2011
Decision Date05/16/2012
Product Code
LOZ[ Registered Establishments with LOZ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00614510
NCT00733447
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE COMPANION 2 DRIVER SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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