SpineSeal Spine Sealant
FDA premarket approval P240027/S004 · decided 2025-11-07
Approval details
- PMA number
- P240027
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SpineSeal Spine Sealant
- Generic name
- Sealant, dural
- Applicant
- Pramand, LLC
- Date received
- 2025-09-30
- Decision date
- 2025-11-07
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for an accelerated aging arm to the shelf-life validation protocol for future shelf life expansions.
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