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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.
 
DevicePreveLeak Surgical Sealant
Generic NameSealant, polymerizing
ApplicantBaxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake, IL 60015
PMA NumberP100030
Supplement NumberS007
Date Received05/30/2017
Decision Date08/25/2017
Product Code NBE 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the pH specification and the ratio of salts for the crosslinker solution component
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