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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 NumberS009
Date Received01/16/2007
Decision Date02/12/2007
Product Code
MUQ[ Registered Establishments with MUQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional precautionary statements, and other minor modifications to the instructions for use of the cartridge and syringe labels.
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