CraniSeal Dural Sealant
FDA premarket approval P220014/S009 · decided 2025-10-10
Approval details
- PMA number
- P220014
- Supplement
- S009
- 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
- 2025-07-14
- Decision date
- 2025-10-10
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval to move the trilysine acetate from the clear precursor syringe to the diluent syringe.
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