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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 VAD SYSTEM; SEALED ARTERIAL CANNULAE, 14 MM AND 18 MM GRAFT
Generic NameVentricular (assist) bypass
ApplicantThoratec Laboratories Corp.
2023 Eighth St.
Berkeley, CA 94710
PMA NumberP870072
Supplement NumberS025
Date Received03/10/2003
Decision Date04/25/2003
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 DESIGN MODIFICATION TO THE ARTERIAL CANNULAE USED WITH THE THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE.
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