SpineSeal Spine Sealant
FDA premarket approval P240027 · decided 2025-02-14
Approval details
- PMA number
- P240027
- Trade name
- SpineSeal Spine Sealant
- Generic name
- Sealant, dural
- Applicant
- Pramand, LLC
- Date received
- 2024-08-19
- Decision date
- 2025-02-14
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- The SpineSeal Spine Sealant is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.
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