PMA P220014S002
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S002
- Product code
- NQR
- Decision date
- 2023-12-20
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- a change to improve the repeatability of a quality control test method for the CraniSeal precursors
Current openFDA PMA Record#
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S002
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2023-12-20
- Decision code
- OK30
- Date received
- 2023-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to improve the repeatability of a quality control test method for the CraniSeal precursors