# LWS: Implantable Cardioverter Defibrillator (Non-Crt)

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 17
- Recalls: 89 (12 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: 162
- 2018: 142
- 2019: 98
- 2020: 125
- 2021: 111
- 2022: 91
- 2023: 101
- 2024: 108
- 2025: 97
- 2026: 93

## Most-cited predicates
- P950022: TVL (TM) Lead System (1996), cited by 3
- P910023: Cadence (R) Tiered Therapy Defibrillation System (1993), cited by 1

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