FDA product code NVN: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
NVN is the FDA product code for drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NVN reach the market by PMA; FDA lists no cleared 510(k)s for it. 15 PMA applications cite this product code.
Definition
Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.
Classification
| Field | Value |
|---|---|
| Device name | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NVN devices
openFDA lists no recalls for product code NVN.
Frequently asked questions
What is FDA product code NVN?
NVN is the FDA product code for drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NVN?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NVN
- Run a recall and safety report across every NVN manufacturer
- Watch product code NVN 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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