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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.
 
Trade NameTHORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC LABORATORIES CORP.
PMA NumberP870072
Date Received11/24/1987
Decision Date12/20/1995
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 97M-0136
Notice Date 04/11/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: 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 
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