MUZ — Stimulator, Autonomic Nerve, Implanted (Depression) Class III

FDA Device Classification

Classification Details

Product Code
MUZ
Device Class
Class III
Regulation Number
Submission Type
Review Panel
NE
Medical Specialty
Unknown
Implant
Yes

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.