PMA P220014S010
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S010
- Product code
- NQR
- Decision date
- 2026-01-16
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- Approval of the revised protocol for the CraniSeal Registry New Enrollment post-approval study.
Current openFDA PMA Record#
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S010
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2026-01-16
- Decision code
- APPR
- Date received
- 2025-12-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the CraniSeal Registry New Enrollment post-approval study.