PMA P040034S040
- Device
- DuraSeal Dural Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S040
- Product code
- NQR
- Decision date
- 2025-12-17
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- addition of an external supplier for in-process PBS solution
Current openFDA PMA Record#
- Device
- DuraSeal Dural Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S040
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2025-12-17
- Decision code
- OK30
- Date received
- 2025-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an external supplier for in-process PBS solution