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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.
 
DevicePROGEL™ Pleural Air Leak Sealant
Generic NameSealant, polymerizing
ApplicantNEOMEND, INC.
60 TECHNOLOGY DR.
IRVINE, CA 92618
PMA NumberP010047
Supplement NumberS069
Date Received01/31/2024
Decision Date03/05/2024
Product Code NBE 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
to change the incoming component embedded particulate specification for the Chemistry Kit Lids and Trays for the PROGEL Pleural Air Leak Sealant and the TRIDYNE Vascular Sealant devices
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