# K020669: Permanent Pacing Lead, Models Petite, Petite R, J, RJ, Petite B, RB, JB, RJB

- Pathway: 510(k) (Special)
- Applicant: Oscor, Inc.
- Decided: Mar 28, 2002 after 27 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Permanent pacing lead, Model Petite™ is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Source page: https://510kreport.com/device/K020669
Methodology: https://510kreport.com/methodology