FDA product code OJX: Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
OJX is the FDA product code for drug eluting permanent left ventricular (lv) pacemaker electrode. It is a Class III device, reviewed by the Cardiovascular panel. Devices under OJX reach the market by PMA; FDA lists no cleared 510(k)s for it. 7 PMA applications cite this product code.
Definition
Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
Classification
| Field | Value |
|---|---|
| Device name | Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for OJX devices
openFDA lists no recalls for product code OJX.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C7538 — Insertion of new or replacement of permanent pacemaker with ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)
- C7540 — Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator, dual lead system, with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system)
- C7539 — Insertion of new or replacement of permanent pacemaker with atrial and ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system)
- C7537 — Insertion of new or replacement of permanent pacemaker with atrial transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)
- G0448 — Insertion or replacement of a permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber with insertion of pacing electrode, cardiac venous system, for left ventricular pacing
Frequently asked questions
What is FDA product code OJX?
OJX is the FDA product code for drug eluting permanent left ventricular (lv) pacemaker electrode. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is OJX?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OJX
- Run a recall and safety report across every OJX manufacturer
- Watch product code OJX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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