OLM

Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)

产品代码

OLM

器械名称

Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)

管理类别

第 F 类（HDE）

FDA 专业组

Unknown

上市路径

HDE - Humanitarian Device Exemption

标记

属植入器械

FDA 分类定义

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).

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。