DuraSeal Exact Spine Sealant System
FDA premarket approval P080013/S030 · decided 2026-02-27
Approval details
- PMA number
- P080013
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DuraSeal Exact Spine Sealant System
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2025-11-24
- Decision date
- 2026-02-27
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Approval for the extension of shelf-life to 18 months.
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