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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 PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER
Generic NameVentricular (assist) bypass
ApplicantThoratec Laboratories Corp.
2023 Eighth St.
Berkeley, CA 94710
PMA NumberP870072
Supplement NumberS028
Date Received03/03/2004
Decision Date08/03/2004
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 A MODIFICATION TO THE CIRCUITRY ASSOCIATED WITH THE BATTERY SUPERVISOR CHIP USED IN THE BATTERY PACKS THAT PROVIDE POWER FOR THE TLC-II PORTABLE PNEUMATIC DRIVER.
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