OBD

Barrier, Adhesion, Cardiovascular

产品代码

OBD

器械名称

Barrier, Adhesion, Cardiovascular

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

Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices. Intended for use in cardiac surgery to prevent or reduce adhesions, and facilitate reoperation in patients who are anticipated to need staged cardiovascular surgeries or repeat procedures in the thoracic region.

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）。