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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 NumberS034
Date Received03/07/2014
Decision Date06/17/2015
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifying the storage conditions of progel pleural air leak. The inclusion of a consecutive or cumulative controlled room temperature storage excursion of 8 °c to 25 °c for a period up to 35 days within the approved 24-month shelf life when the device is normally stored between 2 °c to 8°c.
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