# OJX: Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 3
- 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: 19
- 2018: 24
- 2019: 21
- 2020: 19
- 2021: 19
- 2022: 9
- 2023: 11
- 2024: 7
- 2025: 5
- 2026: 3

## Most-cited predicates

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