Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)
The Deep Brain Stimulator For Obsessive Compulsive Disorder (product code OLM) is a device granted marketing authorization through the Humanitarian Device Exemption (HDE) pathway, reviewed by the Neurology (NE) panel, and is an implanted device. It is indicated for bilateral stimulation of the anterior limb of the internal capsule as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant OCD in adult patients who have failed at least three SSRIs. The device carries an implant flag and, while not life-sustaining, represents a high-risk neurological intervention.
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Basic Information
- Product Code
- OLM
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 6
Device Characteristics
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).
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.