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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 XVE LVAS
Classification Nameventricular (assisst) bypass
Generic Nameleft ventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP920014
Supplement NumberS015
Date Received02/23/2001
Decision Date05/31/2001
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to include the heartmate. Xve lvas under p920014, with the same indications for use as for the previously approved (in supplement s7, approval letter dated october 6, 1998) ve lvas. The device, as modified, will be marketed under the trade name heartmate. Xve lvas and 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. Sve lvas is indicated for use both inside and outside the hospital.
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