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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 AND PROGEL EXTENDED APPLICATOR SPRAY TIP
Generic NameSealant, polymerizing
ApplicantNEOMEND, INC.
60 TECHNOLOGY DR.
IRVINE, CA 92618
PMA NumberP010047
Supplement NumberS037
Date Received03/02/2015
Decision Date03/16/2015
Product Code NBE 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO EXTEND ENROLLMENT BY 13 MONTHS TO COMPLETE ENROLLMENT IN THE PAS TO THE POST-APPROVAL STUDY PROTOCOL.
Post-Approval StudyShow Report Schedule and Study Progress
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