PAX

Surgical Kit

产品代码

PAX

器械名称

Surgical Kit

管理类别

第 F 类（HDE）

FDA 专业组

Unknown

上市路径

HDE - Humanitarian Device Exemption

FDA 分类定义

For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.

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）。