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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 NumberS028
Date Received03/11/2013
Decision Date11/08/2013
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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