PMA P220014S004
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S004
- Product code
- NQR
- Decision date
- 2025-02-11
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- Approval for a change to the syringes that contain the precursor and diluent solution components.
Current openFDA PMA Record#
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S004
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2025-02-11
- Decision code
- APPR
- Date received
- 2024-11-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the syringes that contain the precursor and diluent solution components.