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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 NumberS073
Date Received02/17/2026
Decision Date03/12/2026
Product Code NBE 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
For the reduction of testing frequency for Air Flow Test, Standard Spray Tips and Extended Spray Tips; removal of Neomend Inc. Pouch Peel Strength Testing for Incoming Packaging Materials with the adoption of Supplier-Performed ASTM F88 Testing for Chevron Seal Pouches; and elimination of SDS-PAGE Lot Release Testing
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