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 Exact Spine Sealant System |
Generic Name | Sealant, dural |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P080013 |
Supplement Number | S022 |
Date Received | 03/12/2021 |
Decision Date | 01/25/2023 |
Product Code |
NQR |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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