NKM

Mitral Valve Repair Devices

产品代码

NKM

器械名称

Mitral Valve Repair Devices

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

标记

属植入器械

FDA 分类定义

To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.

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）。