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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePROGEL PLEURAL AIR LEAK SEALANT
Classification Namesealant,polymerizing
Generic Namesurgical sealant
ApplicantNEOMEND, INC.
PMA NumberP010047
Supplement NumberS026
Date Received12/03/2012
Decision Date07/25/2013
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
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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