FDA product code MUZ: Stimulator, Autonomic Nerve, Implanted (Depression)
MUZ is the FDA product code for stimulator, autonomic nerve, implanted (depression). It is a Class III device, reviewed by the Neurology panel. Devices under MUZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for MUZ devices.
Definition
The device is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Autonomic Nerve, Implanted (Depression) |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MUZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-11-13.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code MUZ?
MUZ is the FDA product code for stimulator, autonomic nerve, implanted (depression). It is a Class III device, reviewed by the Neurology panel.
What device class is MUZ?
Class III. Typical premarket route: PMA.
Have MUZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-11-13.
Next steps
- Run an FDA pathway report with predicate devices for product code MUZ
- Run a recall and safety report across every MUZ manufacturer
- Watch product code MUZ 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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