FDA product code PIM: Neuromodulator For Obesity
PIM is the FDA product code for neuromodulator for obesity. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under PIM reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Weight reduction by peripheral neuromodulation.
Classification
| Field | Value |
|---|---|
| Device name | Neuromodulator For Obesity |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PIM devices
openFDA lists no recalls for product code PIM.
Frequently asked questions
What is FDA product code PIM?
PIM is the FDA product code for neuromodulator for obesity. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is PIM?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PIM
- Run a recall and safety report across every PIM manufacturer
- Watch product code PIM 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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