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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 NumberS033
Date Received03/12/2021
Decision Date01/25/2023
Product Code NQR 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for changes to the polycarbonate resin for the spray tip and Y-connector components and to extend the shelf life from 18 months to 24 months for the DuraSeal Dural Sealant System and the DuraSeal Exact Spine Sealant System
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