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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.
 
DeviceTHORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
THORATEC LABORATORIES CORP.
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
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