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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.
 
DeviceBIOGLUE SURGICAL ADHESIVE
Generic NameGlue, surgical, arteries
ApplicantCryolife, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP010003
Supplement NumberS015
Date Received04/30/2010
Decision Date05/12/2010
Product Code MUQ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CLARIFICATION REGARDING ONE OF THE WARNINGS IN THE INSTRUCTIONS FOR USE (IFU).
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