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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.
Planisboro, 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
Predetermined Change Control Plan AuthorizedNo
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: S019 S020  S013 S017 S008 S024 S011 S012 S009 S002 S016 
S007 S006 S025 S023 S021 S001 S003 S004 S005 S014 S015 S026 
S032 S029 S030 S031 S033 S035 S034 S038 S027 S028 S037 S036 
S039 S040 S041 
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