|Trade Name||DURASEAL DURAL SEALANT SYSTEM|
|Classification Name||sealant, dural|
|Generic Name||surgical sealant,polymerizing|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| 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.