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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 NumberS034
Date Received03/07/2014
Decision Date06/17/2015
Product Code NBE 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR MODIFYING THE STORAGE CONDITIONS OF PROGEL PLEURAL AIR LEAK. THE INCLUSION OF A CONSECUTIVE OR CUMULATIVE CONTROLLED ROOM TEMPERATURE STORAGE EXCURSION OF 8 °C TO 25 °C FOR A PERIOD UP TO 35 DAYS WITHIN THE APPROVED 24-MONTH SHELF LIFE WHEN THE DEVICE IS NORMALLY STORED BETWEEN 2 °C TO 8°C.
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