CraniSeal Dural Sealant
FDA premarket approval P220014 · decided 2023-07-06
Approval details
- PMA number
- P220014
- Trade name
- CraniSeal Dural Sealant
- Generic name
- Sealant, dural
- Applicant
- Pramand, LLC
- Date received
- 2022-09-02
- Decision date
- 2023-07-06
- Days to decision
- 307 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for the CraniSeal Dural Sealant. The device is indicated for use in patients >= 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.
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