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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 NumberS030
Date Received08/02/2013
Decision Date09/25/2013
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removal of the upper limit seal strength specification for the sterile barrier pouch packaging and replacing it with the peel-open verification test.
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