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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 EXACT SPINE SEALANT SYSTEM
Generic NameSealant, dural
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP080013
Date Received04/25/2008
Decision Date09/04/2009
Product Code NQR 
Docket Number 09M-0485
Notice Date 10/06/2009
Advisory Committee Neurology
Clinical TrialsNCT00594035
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE DURASEAL XACT SEALANT SYSTEM. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SUTURED DURAL REPAIR DURING SPINAL SURGERY TO PROVIDE WATERTIGHT CLOSURE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 
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