CraniSeal Dural Sealant
FDA premarket approval P220014/S004 · decided 2025-02-11
Approval details
- PMA number
- P220014
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CraniSeal Dural Sealant
- Generic name
- Sealant, dural
- Applicant
- Pramand, LLC
- Date received
- 2024-11-12
- Decision date
- 2025-02-11
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for a change to the syringes that contain the precursor and diluent solution components.
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