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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
Applicant MEDTRONIC INC.
PMA NumberP870072
Supplement NumberS001
Date Received01/30/1996
Decision Date07/10/1996
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding references to the directions for use for the thoratec vad system.
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