ONU

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

产品代码

ONU

器械名称

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

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

A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral.

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）。