CraniSeal Dural Sealant
FDA premarket approval P220014/S006 · decided 2025-05-29
Approval details
- PMA number
- P220014
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CraniSeal Dural Sealant
- Generic name
- Sealant, dural
- Applicant
- Pramand, LLC
- Date received
- 2025-05-01
- Decision date
- 2025-05-29
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- a revision to the swell percent test method
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