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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 NameBIOGLUE SURGICAL ADHESIVE
Classification Nameglue,surgical,arteries
Generic Namesurgical adhesive
ApplicantCRYOLIFE, INC.
PMA NumberP010003
Supplement NumberS017
Date Received08/09/2013
Decision Date09/06/2013
Product Code
MUQ[ Registered Establishments with MUQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a service supplier for pouching the delivery tip extension.
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