DuraSeal Exact Spine Sealant System
FDA premarket approval P080013/S022 · decided 2023-01-25
Approval details
- PMA number
- P080013
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DuraSeal Exact Spine Sealant System
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2021-03-12
- Decision date
- 2023-01-25
- Days to decision
- 684 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- 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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