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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 NameTHORATEC HEARTMATE XVE AND VE LEST VENTRICULAR ASSIST SYSTEM (LVAS)
Classification Nameventricular (assisst) bypass
Generic Nameleft ventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP920014
Supplement NumberS022
Date Received06/16/2003
Decision Date12/02/2003
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified stroke volume limiter design for the heartmate xve and snap-ve devices.
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