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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 VENTRICULAR ASSIST DEVICE SYSTEM
Classification Nameventricular (assisst) bypass
ApplicantTHORATEC CORP.
PMA NumberP870072
Supplement NumberS016
Date Received06/29/2001
Decision Date01/30/2002
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approal for a beveled-tip atrial cannula to replace the original atrial cannula design.
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