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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 VENTRICULAR ASSIST DEVICE(VAD)
Generic Nameventricular (assist) bypass
ApplicantTHORATEC LABORATORIES CORP.
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS057
Date Received11/21/2013
Decision Date12/18/2013
Withdrawal Date 10/05/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE FINAL INSPECTION OF THE THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM.
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