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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS005
Date Received10/06/1997
Decision Date05/21/1998
Product Code
DSQ[ Registered Establishments with 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 Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling