FDA proposes lower risk classification, special controls for external pacemakers

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA proposes lower risk classification, special controls for external pacemakers

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FDA proposes lower risk classification, special controls for external pacemakers

10/17/2011 11:21 AM EDT

Today the U.S. Food and Drug Administration issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III (high-risk) to Class II (moderate-risk).

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