OIR
- 产品代码
- OIR
- 器械名称
- Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
- 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
- 标记
- 属生命支持/维持器械
FDA 分类定义
The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.
FDA 官方分类页： OIR
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。