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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
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP870072
Supplement NumberS052
Date Received03/07/2013
Decision Date04/01/2013
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a new sterilization chamber.
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