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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 Date10/03/2014
Product Code DSQ 
Docket Number 94M-0404
Notice Date 10/03/1996
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE HEARTMATE (R) IP LVAS
Supplements: S031 S006 S007 S001 S003 S004 S002  S015 S025 S009 S023 
S024 S029 S022 S008 S014 S011 S012 S013 S021 S010 S017 S018 
S019 S020 S027 S016 
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