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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. NW
Kennesaw, GA 30144
PMA NumberP010003
Supplement NumberS022
Date Received04/04/2016
Decision Date05/04/2016
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  
Change to the frequency of the bioburden assessments from quarterly to annually for BioGlue Accessories that undergo Ethylene Oxide (EO) sterilization, a modification to the Limulus Amebocyte Lysate (LAL) test method for BioGlue to include agitation during the extraction process and change the dilution to test the BioGlue extract, and to eliminate the quarterly autoclave cycle verification and the quarterly issuance of Certificates of Completion for the autoclaves used in production and microbiology.
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