OOY

Bronchial Thermoplasty System

产品代码: OOY
器械名称: Bronchial Thermoplasty System
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

FDA 分类定义

Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using thermal radiofrequency energy to ablate smooth muscle tissue in the patient's airways.

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： OOY

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。