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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.
PLAINSBORO, NJ 08536
PMA NumberP040034
Supplement NumberS002
Date Received11/17/2005
Decision Date12/13/2005
Product Code NQR 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGING THE PACKAGE CONFIGURATIONS TO INCLUDE A 1 UNIT CONFIGURATION, IDENTIFIED AS "1-UP".
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