CraniSeal Dural Sealant
FDA premarket approval P220014/S008 · decided 2025-08-25
Approval details
- PMA number
- P220014
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CraniSeal Dural Sealant
- Generic name
- Sealant, dural
- Applicant
- Pramand, LLC
- Date received
- 2025-05-27
- Decision date
- 2025-08-25
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for a change to the Indications for Use to include patients greater than or equal to 13 years of age.
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