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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHEARTMATE(R) VE LVAS
Generic NameVentricular (assist) bypass
ApplicantTHORATEC CORP.
6035 STONERIDGE DR.
PLEASANTON, CA 94588
PMA NumberP920014
Supplement NumberS007
Date Received07/02/1997
Decision Date09/29/1998
Withdrawal Date 10/03/2014
Product Code DSQ 
Docket Number 99M-1520
Notice Date 06/09/1999
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
approval for the HeartMate(R) VE LVAS. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The HeartMate(R) VE LVAS is indicated for use both inside and outside the hospital.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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