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