FDA product code PMP: Dorsal Root Ganglion Stimulator For Pain Relief
PMP is the FDA product code for dorsal root ganglion stimulator for pain relief. It is a Class III device, reviewed by the Neurology panel. Devices under PMP reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 2 recalls for PMP devices, 1 initiated in the last five years.
Definition
Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs.
Classification
| Field | Value |
|---|---|
| Device name | Dorsal Root Ganglion Stimulator For Pain Relief |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PMP devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-05-16.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code PMP?
PMP is the FDA product code for dorsal root ganglion stimulator for pain relief. It is a Class III device, reviewed by the Neurology panel.
What device class is PMP?
Class III. Typical premarket route: PMA.
Have PMP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code PMP
- Run a recall and safety report across every PMP manufacturer
- Watch product code PMP 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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