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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceSYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
Classification Nameartificial heart
Generic Nameartificial heart
Applicant
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake rd.
tucson, AZ 85713
PMA NumberP030011
Date Received04/11/2003
Decision Date10/15/2004
Product Code
LOZ[ Registered Establishments with LOZ ]
Docket Number 04M-0471
Notice Date 10/27/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the syncardia temporary cardio west total artificial heart (tah-t). The device is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. Also, the temporary cardiowest total artificial heart (tah-t) is intended for use inside the hospital.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S006 S007 S008 S009 S010 S011 
S012 S013 S015 S016 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S029 S030 S031 S032 S033 
S034 S035 S036 S037 S038 S039 S040 S041 S042 
S043 S044 S045 S046 
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