FDA product code PJS: Stimulator, Electrical, Implanted, For Essential Tremor
PJS is the FDA product code for stimulator, electrical, implanted, for essential tremor. It is a Class III device, reviewed by the Neurology panel. Devices under PJS reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Deep Brain Stimulation for the treatment of essential tremor
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Electrical, Implanted, For Essential Tremor |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PJS devices
openFDA lists no recalls for product code PJS.
Frequently asked questions
What is FDA product code PJS?
PJS is the FDA product code for stimulator, electrical, implanted, for essential tremor. It is a Class III device, reviewed by the Neurology panel.
What device class is PJS?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PJS
- Run a recall and safety report across every PJS manufacturer
- Watch product code PJS 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.