PMA P220014S008
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S008
- Product code
- NQR
- Decision date
- 2025-08-25
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- Approval for a change to the Indications for Use to include patients greater than or equal to 13 years of age.
Current openFDA PMA Record#
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S008
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2025-08-25
- Decision code
- APPR
- Date received
- 2025-05-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change to the Indications for Use to include patients greater than or equal to 13 years of age.