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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(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Generic Nameventricular (assist) bypass
ApplicantTHORATEC LABORATORIES CORP.
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS062
Date Received05/16/2016
Decision Date06/14/2016
Withdrawal Date 10/05/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implementation of a new facility (same supplier) to provide the Battery Pack Assembly TLC II for the Thoratec Ventricular Assist Device (VAD).
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