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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.
 
DeviceTHORATEC TLC-II PORTABLE VAD DRIVER
Generic NameVentricular (assist) bypass
ApplicantThoratec Laboratories Corp.
2023 Eighth St.
Berkeley, CA 94710
PMA NumberP870072
Supplement NumberS037
Date Received07/30/2007
Decision Date11/14/2007
Withdrawal Date10/05/2020
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 FOR REDUCING THE MAINTENANCE SERVICE INTERVAL FOR THE TLC II PORTABLE VAD DRIVER TO 1500 HOURS FROM THE CURRENT 3000 HOUR INTERVAL.
Post-Approval StudyShow Report Schedule and Study Progress
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