MUZ

Stimulator, Autonomic Nerve, Implanted (Depression)

产品代码
MUZ
器械名称
Stimulator, Autonomic Nerve, Implanted (Depression)
管理类别
第 3 类(Class III)
FDA 专业组
Unknown
上市路径
需 PMA 上市前批准
标记
属植入器械

FDA 分类定义

The device is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

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)。

FDA 官方分类页: MUZ
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。