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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 NumberS026
Date Received11/20/2012
Decision Date07/25/2013
Product Code NBE 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE SHIPPING TEMPERATURE RANGE TO 1ºC TO 30°C TO ALLOW FOR BRIEF POSSIBLE EXTREMES IN TEMPERATURE DURING SHIPMENT. THE AGENCY NOTES THAT THE "KEEP REFRIGERATED" LABEL, C-00473, WILL BE AFFIXED TO THE SHIPPING CONTAINER.
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