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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 NamePROGEL PLEURAL AIR LEAK SEALANT
Classification Namesealant,polymerizing
Generic Namesurgical sealant
ApplicantNEOMEND, INC.
PMA NumberP010047
Supplement NumberS021
Date Received07/12/2012
Decision Date09/05/2012
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifications to the push rod (c-00286), end cap (c-00280) and outer housing (c-00279) components of the applicator kit and associated minor labeling changes.
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