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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., N.W.
KENNESAW, GA 30144
PMA NumberP010003
Supplement NumberS041
Date Received09/20/2023
Decision Date10/20/2023
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
Approval Order Statement  
Approval for an additional caution statement regarding use of the device in aortic dissection surgery and other minor updates to the Instructions for Use.
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