# LWO: Pulse-Generator, Single Chamber, Sensor Driven, Implantable

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 0 (0 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: 6
- 2018: 5
- 2019: 1
- 2020: 3
- 2021: 4
- 2022: 3
- 2023: 2
- 2024: 1
- 2025: 5
- 2026: 2

## Most-cited predicates
- P970013: Microny Pacemakers (2000), cited by 1

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