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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 NumberS031
Date Received12/27/2010
Decision Date12/21/2011
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at thoratec corporation in san ramon, california for receiving acceptance activities, receiving inspection, warehousing, and shipping operations.
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