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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.
 
DeviceBIOGLUE SURGICAL ADHESIVE
Classification Nameglue,surgical,arteries
Generic Nameglue,surgical,arteries
Applicant
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, GA 30144
PMA NumberP010003
Supplement NumberS009
Date Received01/16/2007
Decision Date02/12/2007
Product Code
MUQ[ Registered Establishments with MUQ ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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