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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received08/23/2001
Decision Date01/14/2010
Product Code
NBE[ Registered Establishments with NBE ]
Docket Number 10M-0068
Notice Date 01/27/2010
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for progel pleural air leak sealant. The device is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (>=2 mm) incurred during open resection of lung parenchyma.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S026 S027 S028 S029 S030 
S031 S033 
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