OJX — Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Class III

FDA Device Classification

FDA product code OJX covers "Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

Product Code
OJX
Device Class
Class III
Regulation Number
Submission Type
Review Panel
CV
Medical Specialty
Unknown
Implant
Yes

Definition

Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.