PMA P220014S005
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S005
- Product code
- NQR
- Decision date
- 2025-07-02
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- Approval for a change to replace the current Tyvek/PET (Mylar) pouch outer packaging to a Tyvek/Nylon pouch.
Current openFDA PMA Record#
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S005
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2025-07-02
- Decision code
- APPR
- Date received
- 2025-04-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to replace the current Tyvek/PET (Mylar) pouch outer packaging to a Tyvek/Nylon pouch.