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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
Classification Nameglue,surgical,arteries
Generic Nameglue,surgical,arteries
Applicant
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, GA 30144
PMA NumberP010003
Supplement NumberS001
Date Received05/03/2002
Decision Date07/29/2002
Product Code
MUQ[ Registered Establishments with MUQ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR 1) ADDING AN ADDITIONAL VENDOR, DOMNICK HUNTER, PLC, FOR THE 0.2 UM-FILTER TO FILTER BULK COMPONENT SOLUTIONS, AND 2) ADDING A SOLUTION MIXING SYSTEM FOR THE BOVINE SERUM ALBUMIN BULK SOLUTION FOR BAGS UP TO 20L IN CAPACITY.
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