MUZ · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
MUZ
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
NE
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.