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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
Generic NameGlue, surgical, arteries
ApplicantCryolife, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP010003
Supplement NumberS012
Date Received06/06/2008
Decision Date06/24/2008
Product Code MUQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF AN AUTOMATED PUMP FOR DISPENSING BOVINE SERUM ALBUMIN AND GLUTERALDEHYDE IN THE MANUFACTURE OF BIOGLUE® SURGICAL ADHESIVE.
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