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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
Applicant
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, GA 30144
PMA NumberP010003
Supplement NumberS037
Date Received11/27/2019
Decision Date12/20/2019
Product Code MUQ 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
1) An alternate supplier for a device component; 2) a change in quality control sampling of another device component; and 3) a change in the 5mL syringe plungers dimension lower tolerance.
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