FDA product code GZA: Implanted Cerebellar Stimulator
GZA is the FDA product code for implanted cerebellar stimulator. It is a Class III device, regulated under 21 CFR 882.5820 and reviewed by the Neurology panel. Devices under GZA reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for pmas 9/26/84 per 49 fr 26574 on 6/28/84
Classification
| Field | Value |
|---|---|
| Device name | Implanted Cerebellar Stimulator |
| Device class | Class III |
| Regulation | 21 CFR 882.5820 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for GZA devices
openFDA lists no recalls for product code GZA.
Frequently asked questions
What is FDA product code GZA?
GZA is the FDA product code for implanted cerebellar stimulator. It is a Class III device, regulated under 21 CFR 882.5820 and reviewed by the Neurology panel.
What device class is GZA?
Class III, regulation 21 CFR 882.5820. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code GZA
- Run a recall and safety report across every GZA manufacturer
- Watch product code GZA 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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