PGQ
- 产品代码
- PGQ
- 器械名称
- Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- 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
Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.
FDA 官方分类页: PGQ
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。