# NVN: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 12
- 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: 67
- 2018: 86
- 2019: 56
- 2020: 69
- 2021: 60
- 2022: 43
- 2023: 38
- 2024: 36
- 2025: 36
- 2026: 35

## Most-cited predicates
- P960013: Tendril DX Model 1388T & 1388K Endocardial Pacing Leads (1997), cited by 2
- P960030: Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads (1998), cited by 1

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