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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 NameTHORETEC HEARTMATE XVE LVAS
Classification Nameventricular (assisst) bypass
Generic Nameleft ventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP920014
Supplement NumberS017
Date Received11/12/2002
Decision Date04/04/2003
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an expanded indication for use for the thoratec heartmate xve lvas. This device system is indicated for use as a bridge to cardiac transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. It is now also indicated for use in patients with new york heart association class iv end stage left ventricular failure who have received optimal medical therapy for at least 60 of the last 90 days, and who have a life expectancy of less than two years, and who are not eligible for cardiac transplantation. The device system is approved for use both inside and outside the hospital.
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