OLM — Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) Class f
FDA product code OLM covers "Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)", a Class f medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- OLM
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Unknown
- Implant
- Yes
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).