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. |
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Device | DuraSeal Dural Sealant System |
Generic Name | Sealant, dural |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P040034 |
Supplement Number | S030 |
Date Received | 12/30/2019 |
Decision Date | 04/08/2020 |
Product Code |
NQR |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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