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Endocardial Solutions

This article was originally published in The Gray Sheet

Executive Summary

Submits a 510(k) to FDA for the Ensite 3000 3D mapping system for diagnosing arrhythmias in the right atrium of the heart. Under a 1997 investigation device exemption, data for the application were collected at the Cleveland Clinic, Mayo Clinic, Northwestern University Hospital, Temple University Hospital and the University of Michigan Medical Center
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