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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.
 
Trade NameTHORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC LABORATORIES CORP.
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
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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