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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 DEVICE
Generic NameSealant, polymerizing
ApplicantNeomend, Inc.
60 Technology Dr.
Irvine, CA 92618
PMA NumberP010047
Supplement NumberS019
Date Received04/06/2012
Decision Date08/23/2012
Product Code NBE 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN EXTENSION OF THE REFRIGERATED SHELF LIFE OF THE DEVICE.
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