NPV
- 产品代码
- NPV
- 器械名称
- Pulmonary Valve Prosthesis Percutaneously Delivered
- 管理类别
- 第 F 类(HDE)
- 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
These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
FDA 官方分类页: NPV
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。