Xstim Spine Fusion Stimulator
FDA premarket approval P230025/S001 · decided 2024-11-12
Approval details
- PMA number
- P230025
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Xstim Spine Fusion Stimulator
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Xstim, Inc.
- Date received
- 2024-08-14
- Decision date
- 2024-11-12
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Irving, TX
- Statement
- Approval for a software change to extend the maximum total device activation time of the Xstim Spine Fusion Stimulator from 400 days to 1100 days.
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