PMA P080013
- Device
- DuraSeal Exact Spine Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S024
- Product code
- NQR
- Decision date
- 2026-02-27
- Generic name
- Sealant, dural
- Approval order statement
- Approval for the extension of shelf-life to 18 months.
Current openFDA PMA Record#
- Device
- DuraSeal Exact Spine Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S030
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2026-02-27
- Decision code
- APPR
- Date received
- 2025-11-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the extension of shelf-life to 18 months.