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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 NumberS019
Date Received02/07/2003
Decision Date06/29/2004
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post approval study for the device.
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