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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNEOMEND PROGEL PLEURAL AIR LEAK SEALANT
Classification Namesealant,polymerizing
Generic Namesurgical sealant
ApplicantNEOMEND, INC.
PMA NumberP010047
Supplement NumberS002
Date Received03/16/2010
Decision Date04/15/2010
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change from a manual manufacturing process to automated process for filling a component.
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