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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDURASEAL DURAL SEALANT SYSTEM
Generic NameSealant, dural
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP040034
Supplement NumberS016
Date Received01/08/2010
Decision Date05/28/2010
Product Code NQR 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO UPDATE THE CONTENTS OF THE DURASEAL PACKAGE INSERT BASED ON THE RESULTS OF THE POST-APPROVAL STUDY.
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