OJXClass III

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Unknown

OJX is the FDA product code for Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode, a class III device type. FDA's definition for this code reads: "Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: OJX
Device name: Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA definition: Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: Yes
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order

Recent clearances

Product code OJX

FDA records hold no clearances under product code OJX.

Recent recalls

Product code OJX

FDA records show no recalls under product code OJX.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)