Product Classification

• Device: deep brain stimulator for obsessive compulsive disorder (ocd)
• Definition: The device is indicated for bilateral stimulation of the anterior limb of the internal capsule, this device is indicated as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant Obsessive Compulsive Disorder (OCD) in adult patients who have failed at least three Selective Serotonin Reuptake Inhibitors (SSRIs).
• Physical State: Electrodes, extension and IPG
• Technical Method: Deep brain stimulation
• Target Area: Anterior limb of the internal capsule in the brain
• Review Panel: Neurology
• Product Code: OLM
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neuromodulation and Rehabilitation Devices (DHT5B)
• Submission Type: HDE - Humanitarian Device Exemption
• Device Class: HDE
• 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