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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.
Generic Nameventricular (assist) bypass
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS005
Date Received10/06/1997
Decision Date05/21/1998
Withdrawal Date 10/05/2020
Product Code DSQ 
Docket Number 99M-1521
Notice Date 06/09/1999
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Thoratec(R) Ventricular Assist Device (VAD) System. This device is now also indicated for post-cardiotomy patients who are unable to be weaned from cardiopulmonary bypass.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness