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
• Premarket Review: Neuromodulation and Rehabilitation Devices (DHT5B); Neuromodulation and Rehabilitation Devices (DHT5B)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 17-15 ISO 14708-3 Second edition 2017-04
  Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators

Third Party Review

Not Third Party Eligible