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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 LEAK SEALANT
Classification Namesealant,polymerizing
Generic Namesurgical sealant
ApplicantNEOMEND, INC.
PMA NumberP010047
Supplement NumberS016
Date Received01/30/2012
Decision Date03/23/2012
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an extension of shelf life of the progel extended applicator spray tips form 12 to 24 months. The device, as modified, will be marketed under the trade name progel extended applicator spray tips and is indicated to deliver progel to visceral pleura during an open thoracotomy after standard visceral pleural closure (i. E. With sutures or staples) of visible air leaks (>= 2 mm) incurred during open resection of lung parenchyma in adult humans by bending the malleable tip to direct progel from the delivery tip in a stream or spray cone pattern that is perpendicular to the target surface.
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