# LGW: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 8
- Recalls: 42 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 94
- 2018: 64
- 2019: 69
- 2020: 52
- 2021: 56
- 2022: 60
- 2023: 63
- 2024: 94
- 2025: 65
- 2026: 56

## Most-cited predicates

Source page: https://510kreport.com/product-code/LGW
Data by year (CSV): https://510kreport.com/product-code/LGW.csv