POI

Lung Tissue Sealant For Lung Volume Reduction

产品代码: POI
器械名称: Lung Tissue Sealant For Lung Volume Reduction
管理类别: 第 N 类（Not Classified）
FDA 专业组: Unknown
上市路径: Contact ODE
标记: 属植入器械

FDA 分类定义

The system is intended to reduce lung volume irreversibly by employing a synthetic polymer to seal airways in order to improve lung function and quality of life in patients with advanced emphysema. It functions by physically occluding both small airways and collateral air channels through sealing lung tissue, causing the treated area to collapse via absorption atelectasis. It is a single use device intended to be used by pulmonologists and thoracic surgeons in a bronchoscopy suite or operating room.

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： POI

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。