# NVZ: Pulse Generator, Permanent, Implantable

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 5
- Recalls: 25 (7 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: 61
- 2018: 59
- 2019: 60
- 2020: 73
- 2021: 40
- 2022: 44
- 2023: 39
- 2024: 42
- 2025: 39
- 2026: 24

## Most-cited predicates
- P890003: Synergyst  II Pulse Generator Models 7070 & 7071 (1989), cited by 1

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