PMA P230025S001
- Device
- Xstim Spine Fusion Stimulator
- Applicant
- Xstim, Inc.
- PMA number
- P230025
- Supplement
- S001
- Product code
- LOF
- Decision date
- 2024-11-12
- Classification
- Orthopedic
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order 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.
Current openFDA PMA Record#
- Device
- Xstim Spine Fusion Stimulator
- Applicant
- Xstim, Inc.
- PMA number
- P230025
- Supplement
- S001
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2024-11-12
- Decision code
- APPR
- Date received
- 2024-08-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.