Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved...180天补充申报，系指针对已获批的相关主体，就其组件、材料、设计、技术规格、软件、着色添加剂及标签等维度提出重大变更的申请。