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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 NameHEARTMATE II VENTRICULAR ASSISTE SYSTEM
Classification Nameventricular (assisst) bypass
ApplicantTHORATEC CORP.
PMA NumberP060040
Supplement NumberS017
Date Received04/18/2012
Decision Date05/17/2012
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the cored solder wire formulation.
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