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FDA Panel Supports Class II Status For Oxygenation Circuit Devices, And Two Other Categories

This article was originally published in The Gray Sheet

Executive Summary

The Circulatory System Devices Panel supported class II, with special controls, reclassification proposals from FDA for extracorporeal membrane oxygenators; external cardiac compressors; and external pacemaker pulse generators and triple chamber pacing system analyzers. But the panel had some additional requests for further action by the agency.

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