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Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device. Final order.

出版信息

Fed Regist. 2016 Oct 17;81(200):71370-1.

PMID:27901558
Abstract

The Food and Drug Administration (FDA) is classifying the apical closure device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the apical closure device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

摘要

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