NKE

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

产品代码

NKE

器械名称

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

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

标记

属生命支持/维持器械

FDA 分类定义

These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.

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）。