FDA product code SGS: Deep Brain Stimulation For The Treatment Of Dystonia
SGS is the FDA product code for deep brain stimulation for the treatment of dystonia. It is a Class III device, reviewed by the Neurology panel. Devices under SGS reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
To stimulate deep brain structure to manage dystonia symptoms
Classification
| Field | Value |
|---|---|
| Device name | Deep Brain Stimulation For The Treatment Of Dystonia |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for SGS devices
openFDA lists no recalls for product code SGS.
Frequently asked questions
What is FDA product code SGS?
SGS is the FDA product code for deep brain stimulation for the treatment of dystonia. It is a Class III device, reviewed by the Neurology panel.
What device class is SGS?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SGS
- Run a recall and safety report across every SGS manufacturer
- Watch product code SGS 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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