PMA P240027S004
- Device
- SpineSeal™ Spine Sealant
- Applicant
- Pramand, LLC
- PMA number
- P240027
- Supplement
- S004
- Product code
- NQR
- Decision date
- 2025-11-07
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- Approval for an accelerated aging arm to the shelf-life validation protocol for future shelf life expansions.
Current openFDA PMA Record#
- Device
- SpineSeal™ Spine Sealant
- Applicant
- Pramand, LLC
- PMA number
- P240027
- Supplement
- S004
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2025-11-07
- Decision code
- APPR
- Date received
- 2025-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an accelerated aging arm to the shelf-life validation protocol for future shelf life expansions.