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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.
 
Trade NameDURASEAL EXACT SPINE SEALANT SYSTEM
Classification Namesealant, dural
ApplicantINTEGRA LIFESCIENCES CORPORATION
PMA NumberP080013
Date Received04/25/2008
Decision Date09/04/2009
Product Code
NQR[ Registered Establishments with NQR ]
Docket Number 09M-0485
Notice Date 10/06/2009
Advisory Committee Neurology
Clinical Trials NCT00594035
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 
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