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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.
 
DeviceTHORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Generic NameVentricular (assist) bypass
ApplicantTHORATEC LABORATORIES CORP.
2023 EIGHTH ST.
BERKELEY, CA 94710
PMA NumberP870072
Date Received11/24/1987
Decision Date12/20/1995
Withdrawal Date 10/05/2020
Product Code DSQ 
Docket Number 97M-0136
Notice Date 04/11/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
INTENDED AS A BRIDGE TO CARDIAC TRANSPLANTATION FOR USE IN PATIENTS SUFFERING FROM END-STAGE HEART FAILURE. THE PATIENT SHOULD MEET ALL OF THE FOLLOWING CRITERIA: 1)CANDIDATE FOR CARDIAC TRANSPLANTATION, 2) IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, AND 3) DEPENDENCE O N, OR INCOMPLETE RESPONSE TO, CONTINUE VASOPRESSOR SUPPORT
Supplements: S060  S001 S002 S003 S004 S005 S006 S007 S009 S010 S011 
S012 S013 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S033 S034 S035 S036 S037 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S054 S055 S056 S057 S058 S059 S061 S062 
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