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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 NumberS039
Date Received06/21/2024
Decision Date10/30/2024
Product Code NQR 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a change in the vented vial adapter component for the diluent syringe to connect to the polyethylene glycol (PEG) powder vial of the DuraSeal Dural Sealant System and DuraSeal Exact Spine Sealant System, which also resulted in changes to the PEG powder vial closure system, usability, labeling, and packaging.
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