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FDA panel dispute date set for CardioGenesis:

This article was originally published in Clinica

Executive Summary

An independent panel from the US FDA is scheduled to meet on August 20 to help settle a dispute over CardioGenesis' application to market its percutaneous heart laser treatment for angina. The medical devices dispute resolution panel consists of a body of experts authorised to mediate scientific disputes between an applicant and the FDA. It will review and make recommendations concerning the agency's decision to reject the Foothill Ranch, California firm's premarket approval application last year (see Clinica No 1047, p 21). Its recommendation will be made to director of the FDA's Center for Devices and Radiological Health. CardioGenesis is only the second firm to make use of the panel. LifeCore Biomedical was the first in 2001 (see Clinica No 974, p 9).

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