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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 NumberS042
Date Received12/28/2015
Decision Date01/26/2016
Product Code NBE 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF ALTERNATE SUPPLIERS OF TESTING REAGENTS USED FOR ANALYTICAL TESTING (I.E., THE BIURET TEST REAGENT AND PROTEIN PRIMARY STANDARD) OF THE TOTAL PROTEIN CONTENT OF THE HUMAN SERUM ALBUMIN (HAS) COMPONENT OF THE PROGEL PALS FINISHED DEVICE.
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