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FDA Proposes Class II Status For External Pacemaker Pulse Generators, Analyzers

This article was originally published in The Gray Sheet

Executive Summary

External pacemaker pulse generators and pacing system analyzers would move from class III to class II with special controls in a Sept. 15 proposed order. For most of the products, the 510(k) route would be maintained, but triple-chamber PSAs would move from PMA to 510(k) review under the proposal. .

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