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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, Preveleak 10-Pack delivery Tips
Generic NameSealant, polymerizing
ApplicantBaxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake, IL 60015
PMA NumberP100030
Supplement NumberS019
Date Received05/24/2024
Decision Date06/06/2024
Product Code NBE 
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  
supplier to conduct the Dynamic Mechanical Analysis (DMA) test
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