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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 NameHEARTMATE VE LVAS
Classification Nameventricular (assisst) bypass
Generic Nameleft ventricular assist device
ApplicantTHERMO CARDIOSYSTEMS, INC.
PMA NumberP920014
Date Received03/30/1992
Decision Date09/30/1994
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 94M-0404
Notice Date 10/03/1996
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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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