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Medical Device Compliance

FDA Takes Enforcement Action Against CardioMEMS For Alleged Clinical Trial Violations

This article was originally published in The Gray Sheet

Executive Summary

A warning letter cites violations related to the pivotal trial of the firm's Champion HF implantable heart failure monitor.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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