PMA P220014S012
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S012
- Product code
- NQR
- Decision date
- 2026-08-05
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- Approval for a modification to the shelf-life protocol to incorporate use of accelerated aged samples followed by confirmation with real-time aged samples.
Current openFDA PMA Record#
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S012
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2026-08-05
- Decision code
- APPR
- Date received
- 2026-05-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a modification to the shelf-life protocol to incorporate use of accelerated aged samples followed by confirmation with real-time aged samples.