FDA product code OVJ: Pulse Generator, External Pacemaker, Dual Chamber
OVJ is the FDA product code for pulse generator, external pacemaker, dual chamber. It is a Class II device, regulated under 21 CFR 870.3600 and reviewed by the Cardiovascular panel. Devices under OVJ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction.
Classification
| Field | Value |
|---|---|
| Device name | Pulse Generator, External Pacemaker, Dual Chamber |
| Device class | Class II |
| Regulation | 21 CFR 870.3600 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Recalls for OVJ devices
openFDA lists no recalls for product code OVJ.
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)
Frequently asked questions
What is FDA product code OVJ?
OVJ is the FDA product code for pulse generator, external pacemaker, dual chamber. It is a Class II device, regulated under 21 CFR 870.3600 and reviewed by the Cardiovascular panel.
What device class is OVJ?
Class II, regulation 21 CFR 870.3600. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OVJ
- Run a recall and safety report across every OVJ manufacturer
- Watch product code OVJ 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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