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AdvaMed posts reporting guidelines

This article was originally published in The Gray Sheet

Executive Summary

Trade association finalizes its March 2006 proposal for implantable defibrillator and pacemaker performance reporting Jan. 30. The 1guidelines, "Industry Guidance: Uniform Reporting of Clinical Performance of Pulse Generators," call for companies to present device performance data in two separate groups, one for all device problems and another reflecting only malfunctions. Drafted by AdvaMed's ICD/Pacemaker working group, which includes representatives from Guidant, Medtronic, St. Jude Medical and Biotronik, the guidelines have largely been adopted by industry, AdvaMed says (2"The Gray Sheet" March 27, 2006, p. 4). The Heart Rhythm Society released its final recommendations on device performance reporting in September (3"The Gray Sheet" Oct. 2, 2006, p. 3)...
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