Product Classification

• Device: stimulator, autonomic nerve, implanted (depression)
• 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.
• Review Panel: Neurology
• Product Code: MUZ
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 14708-3 2008-11-15 Implants for Surgery - Active implantable medical devices Part 3: Implantable neurostimulators
• AAMI/ANSI/ISO 14708-3 2008-01-01 Implants for surgery - Active implantable medical devices Part 3: Implantable neurostimulators

Third Party Review

Not Third Party Eligible