510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MUZClass III

Stimulator, Autonomic Nerve, Implanted (Depression)

Unknown
FDA source (opens on fda.gov)

MUZ is the FDA product code for Stimulator, Autonomic Nerve, Implanted (Depression), a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
MUZ
Device name
Stimulator, Autonomic Nerve, Implanted (Depression)
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code