The FDA handed Atlanta-based CardioMEMS a warning letter for deviations related to a clinical investigation and premarket approval application (PMA) for its CardioMEMS HF Pressure Measurement System.
According to the June 5 letter posted to the FDA’s website Sept. 25, CardioMEMS failed to submit an accurate investigational plan describing how the Champion heart failure monitoring system (CHAMPION) study would be conducted. Specifically, the protocol did not indicate that the company would make recommendations to investigators about medical management.
That fact was mentioned in an executive summary that CardioMEMS’ presented to the Circulatory Systems Device Panel for a Dec. 8, 2011, meeting on the implantable heart device, as well as a 2007 email to the FDA, the letter notes.
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