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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 HEARTMATE II LVAS
Classification Nameventricular (assisst) bypass
ApplicantTHORATEC CORP.
PMA NumberP060040
Supplement NumberS002
Date Received11/20/2008
Decision Date12/03/2008
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a caution statement ''warning: preclot the graft!" to the package labels for the outflow graft with bend relief (catalog# 102563) and inflow conduit (catalog # 102564). This caution statement is to highlight information currently found in the heartmate ii instructions for use, section 13. 4, which instructs users to pre-clot the two components prior to implantation.
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