# LWP: Implantable Pulse Generator, Pacemaker (Non-Crt)

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 18
- Recalls: 104 (26 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: 116
- 2018: 97
- 2019: 88
- 2020: 90
- 2021: 70
- 2022: 65
- 2023: 54
- 2024: 58
- 2025: 46
- 2026: 40

## Most-cited predicates
- P840068: Delta Pacemaker Sys; Vigor DDD Model 950 (1985), cited by 1

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