# DTB: Permanent Pacemaker Electrode

- Device class: 3; regulation: 21 CFR 870.3680; FDA's rule: PMA required
- FDA decisions: 490
- Recalls: 8 (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: 5
- 2018: 6
- 2019: 7
- 2020: 6
- 2021: 3
- 2022: 4
- 2023: 7
- 2024: 3
- 2025: 1
- 2026: 2

## Most-cited predicates
- K902672: Intermedics 430-07 Bipol Implant Endocard Pac Lead (1991), cited by 4
- K980869: Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and 120 143 (1998), cited by 3
- K954719: Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead (1996), cited by 3
- K922972: Models 438-05 and 435-05 Implantable Pacing Lead (1993), cited by 3
- K883602: Biopore VS.1 Endocardial Inter Implant Pacing Lead (1988), cited by 3
- K890411: Models 432-03 & 433-03 Implantable Pacing Leads (1989), cited by 2
- K912235: Models 432-03 & 433-03 Implant Endocard Pac Lead (1991), cited by 2
- K010281: Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBP (2002), cited by 2
- K904255: Focus T41,T41F,T43, T43F,T44F (1991), cited by 2
- K896742: Focus J81F, J83F, J41F, J43F Pacing Leads (1990), cited by 2

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