OOB

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

产品代码

OOB

器械名称

Drug-Eluting Percutaneous Transluminal Coronary 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 percutaneous transluminal coronary angioplasty catheter is a combination product intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A drug-eluting ptca catheter may also be intended for the treatment of acute myocardial infarction; Treatment of in-stent restenosis (isr) and/or post-deployment stent expansion. A drug-eluting ptca catheter delivers a drug to the vessel as part of the angioplasty procedure, which is intended to inhibit restenosis.

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）。