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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHEARTMATE(R) VE LVAS
Classification Nameventricular (assisst) bypass
Generic Nameleft ventricular assist device
ApplicantTHERMO CARDIOSYSTEMS, INC.
PMA NumberP920014
Supplement NumberS007
Date Received07/02/1997
Decision Date09/29/1998
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 99M-1520
Notice Date 06/09/1999
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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