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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, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/
Generic NameSealant, polymerizing
ApplicantNeomend, Inc.
60 Technology Dr.
Irvine, CA 92618
PMA NumberP010047
Supplement NumberS039
Date Received05/28/2015
Decision Date06/26/2015
Product Code NBE 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADD A SECOND SUPPLIER FOR THE BIOBURDEN TESTING, WHICH IS PERFORMED ON A QUARTERLY BASIS TO CONFIRM BIOBURDEN LEVELS PRIOR TO RELEASE OF THE EXTENDED APPLICATOR SPRAY TIPS FOR ETHYLENE OXIDE STERILIZATION REMAIN ACCEPTABLE.
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