QCD

Continuous Glucose Monitor, Implanted, Adjunctive Use

产品代码

QCD

器械名称

Continuous Glucose Monitor, Implanted, Adjunctive Use

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

The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.

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）。