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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 Exact Spinal Sealant
Generic NameSealant, dural
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP080013
Supplement NumberS025
Date Received01/17/2023
Decision Date02/16/2023
Product Code NQR 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changing the test method from the oxidizable substances test to the total organic carbon test for the water for injection and changing the high-performance liquid chromatography test method to determine the purity of trilysine
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