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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROGEL PLEURAL AIR LEAK SEALANT
Generic NameSealant, polymerizing
ApplicantNEOMEND, INC.
60 TECHNOLOGY DR.
IRVINE, CA 92618
PMA NumberP010047
Supplement NumberS036
Date Received07/11/2014
Decision Date02/13/2015
Product Code NBE 
Docket Number 15M-0502
Notice Date 03/19/2015
Advisory Committee Anesthesiology
Clinical TrialsNCT01394978
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PROGEL PLEURAL AIR LEAK SEALANT (PALS). THE SINGLE USE PROGEL PLEURAL AIR LEAK SEALANT DEVICE IS INDICATED FOR APPLICATION TO VISCERAL PLEURA AFTER STANDARD VISCERAL PLEURAL CLOSURE WITH, FOR EXAMPLE, SUTURES OR STAPLES, OF VISIBLE AIR LEAKS INCURRED DURING RESECTION OF LUNG PARENCHYMA.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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