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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 NumberS022
Date Received08/20/2012
Decision Date04/04/2013
Product Code NBE 
Advisory Committee Anesthesiology
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGE TO A RESIN SUPPLIER.
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