Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
Generic Nameartificial heart
ApplicantSYNCARDIA SYSTEMS, LLC
1992 e. silverlake rd.
tucson, AZ 85713
PMA NumberP030011
Date Received04/11/2003
Decision Date10/15/2004
Product Code LOZ 
Docket Number 04M-0471
Notice Date 10/27/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S047 S048 S049 S050 S051 S052 S007 S054 S055 S010  S021 
S027 S022 S031 S012 S025 S003 S008 S009 S038 S039 S040 S041 
S042 S043 S044 S045 S046 S035 S036 S023 S019 S020 S029 S006 
S001 S002 S032 S033 S034 S030 S026 S024 S013 S015 S016 S037 
S011 S082 S080 S056 S057 S058 S059 S060 S061 S062 S065 S066 
S067 S068 S069 S070 S071 S072 S073 S074 S076 S077 S078 S079