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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 LVAS SYSTEM
Generic NameVentricular (assist) bypass
ApplicantThoratec Corp
6035 Stoneridge Dr.
Pleasanton, CA 94588
PMA NumberP920014
Supplement NumberS025
Date Received12/27/2004
Decision Date03/22/2005
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT TRI-STATE HOSPITAL SUPPLY CORPORATION, YUMA, ARIZONA AND FOR A CHANGE IN THE CYTOTOXICITY TESTING PROCESS.
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