指定预期性能、设计属性、材料和设计的要求 评估、制造、灭菌包装和供应商提供的信息 制造商包括用于治疗血管病变或狭窄的血管支架，或 其他血管异常。这些装置可能包括也可能不包括表面 支架的修改，如药物和/或其他涂层。

Specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. Includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices may or may not incorporate surface modifications of the stent such as drug and/or other coatings.