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U.S. Department of Health and Human Services

Product Classification

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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 CodeOLM
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE - Humanitarian Device Exemption
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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