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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHEARTMATE XVE LVAS
Generic NameVentricular (assist) bypass
ApplicantThoratec Corp
6035 Stoneridge Dr.
Pleasanton, CA 94588
PMA NumberP920014
Supplement NumberS031
Date Received12/27/2010
Decision Date12/21/2011
Withdrawal Date10/03/2014
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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