PMA P040034S031
- Device
- DuraSeal Dural Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S031
- Product code
- NQR
- Decision date
- 2020-08-17
- Generic name
- Sealant, dural
- Approval order statement
- Approval for the addition of a silver colorant to the syringe plunger shaft.
Current openFDA PMA Record#
- Device
- DuraSeal Dural Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S031
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2020-08-17
- Decision code
- APPR
- Date received
- 2020-05-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of a silver colorant to the syringe plunger shaft.