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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDURASEAL DURAL SEALANT SYSTEM
Generic NameSealant, dural
ApplicantINTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536
PMA NumberP040034
Date Received07/20/2004
Decision Date04/07/2005
Product Code NQR 
Docket Number 05M-0191
Notice Date 05/18/2005
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 
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