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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 NameDURASEAL DURAL SEALANT SYSTEM
Classification Namesealant, dural
Generic Namesurgical sealant,polymerizing
ApplicantCOVIDIEN
PMA NumberP040034
Supplement NumberS014
Date Received10/13/2009
Decision Date12/08/2009
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the duraseal ¿instructions for use¿ insert and an update to the graphics found on the polymer kit¿s tyvek lid.
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