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Medtronic

This article was originally published in The Gray Sheet

Executive Summary

Meets with FDA March 11 to discuss a "defibrillator lead device system." Participants from the agency included: Bruce Burlington, director of the device center; Amanda Pedersen, chief mediator and ombudsman; Joseph Levitt, deputy director for regulations and policy; Elizabeth Jacobson, deputy director for science; Susan Alpert, acting director of the Office of Device Evaluation; Janet Arrowsmith-Lowe, acting director of the Office of Surveillance and Biometrics; and Kathy Backinger, OSB. Also attending were Daniel Schaber, Medtronic's manager, tachyarrhythmia and special product clinical evaluation; David Steinhaus, MD, St. Luke's Mid America Heart Institute and a Transvene investigator; Ronald Lund, Medtronic's VP and general counsel; and George Burditt of the law firm Burditt & Radzius
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