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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCRYOLIFE BIOGLUE SURGICAL ADHESIVE
Classification Nameglue,surgical,arteries
Generic Nameglue,surgical,arteries
Applicant
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, GA 30144
PMA NumberP010003
Supplement NumberS004
Date Received09/21/2004
Decision Date10/20/2004
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 ADDING A BOXED WARNING TO BE ADDED TO THE LABELING.
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