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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 LVAS
Classification Nameventricular (assisst) bypass
ApplicantTHORATEC CORP.
PMA NumberP060040
Supplement NumberS016
Date Received02/28/2012
Decision Date03/29/2012
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for providing additional information in the labeling regarding proper engagement of the bend relief with the sealed outflow graft of the device at the time of implant.
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