NAP

Cardiac Support Mesh Wrap

产品代码

NAP

器械名称

Cardiac Support Mesh Wrap

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 device is a passive mesh wrap that is placed around both ventricles of the heart; The intention is to inhibit further dilatation of the ventricles and thus to facilitate reverse remodeling of the myocardium. The device is indicated for use in adult patients diagnosed with dilated cardiomyopathy who are symptomatic in spite of optimal medical therapy. The device can be used alone or in conjunction with mitral valve repair or replacement, if the later therapy is judged appropriate.

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）。