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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 (PALS)
Generic NameSealant, polymerizing
ApplicantNeomend, Inc.
60 Technology Dr.
Irvine, CA 92618
PMA NumberP010047
Supplement NumberS046
Date Received08/28/2017
Decision Date07/03/2018
Product Code NBE 
Advisory Committee Anesthesiology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for manufacturing changes regarding the silicone concentration and application methods to the glass cartridges containing the chemical pre-gel components of the PROGEL Pleural Air Leak Sealant (PALS) device.
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