# K963738: Stela Model BJ44 and BJ45 Pacing Leads

- Pathway: 510(k) (Traditional)
- Applicant: Ela Medical, Inc.
- Decided: May 23, 1997 after 248 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
Longest line of descent: 1 generation back to K896742 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904255: Focus T41,T41F,T43, T43F,T44F, Elamedical (1991) Summary page 1.
- K896742: Focus J81F, J83F, J41F, J43F Pacing Leads, Ela Medical, Inc. (1990) Summary page 1.

## Indications for use
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. ELA Medical Stela ™ Model BJ44 and BJ45 bipolar pacing leads are intended for atrial implantation only.

Source page: https://510kreport.com/device/K963738
Methodology: https://510kreport.com/methodology