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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameCRYOLIFE INC. BIOGLUE SURGICAL ADHESIVE
Classification Nameglue, surgical, arteries
Generic Nameglue, surgical, arteries
Applicant
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, GA 30144
HDE NumberH990007
Supplement NumberS001
Date Received01/10/2001
Decision Date03/29/2001
Product Code
MUQ[ Registered Establishments with MUQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Expansion of bioglue shelf life, expansion of delivery system shelf life, increasing monomer to polymer absorbance ratio, addition of kennesaw, ga facility for packaging, and expansion of resterilization parameters.
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