CraniSeal Dural Sealant
FDA premarket approval P220014/S005 · decided 2025-07-02
Approval details
- PMA number
- P220014
- Supplement
- S005
- 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
- 2025-04-02
- Decision date
- 2025-07-02
- 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 replace the current Tyvek/PET (Mylar) pouch outer packaging to a Tyvek/Nylon pouch.
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