PMA P220014S007
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S007
- Product code
- NQR
- Decision date
- 2025-06-04
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- approval to modify the preparation of samples used in disappearance release testing
Current openFDA PMA Record#
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S007
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2025-06-04
- Decision code
- OK30
- Date received
- 2025-05-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to modify the preparation of samples used in disappearance release testing