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In Brief: EDAP Technomed Group

This article was originally published in The Gray Sheet

Executive Summary

EDAP Technomed Group: Receives approvable letter from FDA for its premarket approval application for the Prostatron microthermy system, which is intended to treat benign prostatic hyperplasia. In October, FDA's Gastroenterology and Urology Devices Panel deemed the PMA approvable, based on the fulfillment of certain conditions ("The Gray Sheet" Oct. 23, p. 6). The agency sent the approvable letter during the week of Nov. 20, FDAers say...



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