MUZ
- 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.
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。