FDA product code SFJ: Vagus Nerve Stimulator For Rheumatoid Arthritis
SFJ is the FDA product code for vagus nerve stimulator for rheumatoid arthritis. It is a Class III device, reviewed by the Neurology panel. Devices under SFJ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Implantable vagus nerve stimulator for Rheumatoid Arthritis
Classification
| Field | Value |
|---|---|
| Device name | Vagus Nerve Stimulator For Rheumatoid Arthritis |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for SFJ devices
openFDA lists no recalls for product code SFJ.
Frequently asked questions
What is FDA product code SFJ?
SFJ is the FDA product code for vagus nerve stimulator for rheumatoid arthritis. It is a Class III device, reviewed by the Neurology panel.
What device class is SFJ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SFJ
- Run a recall and safety report across every SFJ manufacturer
- Watch product code SFJ 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times