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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.
 
DeviceCoseal Spray Set
Generic NameSealant, polymerizing
ApplicantBaxter Bio Science
32650 N Wilson Rd.
Mail Stop Wg2-3s
Round Lake,, IL 60073
PMA NumberP030039
Supplement NumberS031
Date Received07/24/2025
Decision Date08/21/2025
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  
changing the cutting of the tubing from a manual to an automated process for the COSEAL Spray Set
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