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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/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
Predetermined Change Control Plan AuthorizedNo
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: S011 S010  S019 S020 S032 S033 S034 S003 S044 S045 S046 
S074 S048 S049 S050 S051 S052 S054 S009 S001 S008 S006 S043 
S055 S047 S057 S058 S059 S056 S068 S069 S070 S071 S072 S080 
S084 S085 S087 S088 S092 S089 S096 S062 S060 S061 S064 S073 
S076 S086 S099 S002 S007 S031 S037 S038 S026 S012 S013 S015 
S016 S030 S022 S039 S023 S035 S036 S027 S029 S025 S079 S065 
S077 S078 S066 S067 S021 S097 S024 S081 S082 S093 S040 S041 
S042 
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