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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBIOGLUE SURGICAL ADHESIVE
Classification Nameglue,surgical,arteries
Generic Namesurgical adhesive
ApplicantCRYOLIFE, INC.
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: manufacturing
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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