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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesealant, dural
Generic Namesealant, dural
311 enterprise dr.
plainsboro, NJ 08536
PMA NumberP040034
Date Received07/20/2004
Decision Date04/07/2005
Product Code
NQR[ Registered Establishments with NQR ]
Docket Number 05M-0191
Notice Date 05/18/2005
Advisory Committee Neurology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the duraseal dural sealant system. The device is indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. Duraseal should only be used with autologous duraplasty material.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S012 S013 S014 S015 S016 S017 S019 S020 
S021 S023 S024 S025