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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 NumberS013
Date Received08/27/2009
Decision Date10/09/2009
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to identify alternate applicators for use with the device. The device is indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.
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