- Device
- DuraSeal Dural Sealant System.
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S034
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2021-11-17
- Decision code
- OK30
- Date received
- 2021-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional cleaning step to the existing DuraSeal Dural Sealant System and DuraSeal Exact Spine Sealant System manufacturing processes prior to solution filtering.