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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.
 
DeviceTCI HEARTMATE VE LVAS
Generic NameVentricular (assist) bypass
ApplicantThoratec Corp
6035 Stoneridge Dr.
Pleasanton, CA 94588
PMA NumberP920014
Supplement NumberS013
Date Received09/15/2000
Decision Date10/20/2000
Withdrawal Date10/03/2014
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO MODIFY THE HEARTMATE VE SYSTEM CONTROLLER (C/N 1215) TO ACCOMODATE A NEW FOUR CELL BATTERY MODULE (BATTERY CELL), RESULTING IN VE SYSTEM CONTROLLER C/N 1216 AND BATTERY MODULE C/N 1264.
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