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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 System
Generic NameSealant, dural
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP080013
Supplement NumberS018
Date Received12/30/2019
Decision Date04/08/2020
Product Code NQR 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Steris Isomedix Operations, 2 Nucifora Boulevard, Chester, New York 10918, to provide electron beam sterilization of the DuraSeal Exact System and DuraSeal Dural Sealant System.
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