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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.
 
DeviceHEARTMATE VE LVAS
Generic NameVentricular (assist) bypass
ApplicantTHORATEC CORP.
6035 STONERIDGE DR.
PLEASANTON, CA 94588
PMA NumberP920014
Date Received03/30/1992
Decision Date09/30/1994
Withdrawal Date 10/03/2014
Product Code DSQ 
Docket Number 94M-0404
Notice Date 10/03/1996
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE HEARTMATE (R) IP LVAS
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S027 S029 S031 
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