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In Brief: Telectronics

This article was originally published in The Gray Sheet

Executive Summary

Telectronics: Suspends U.S. product shipments under consent decree with FDA, firm announces May 19. According to Telectronics, the decree sets "specific steps" the firm must take to assure FDA that it is in compliance with good manufacturing practices regs. The agreement does not affect products already implanted or already shipped, or products for export outside U.S. Telectronics President Jim Dennis stresses that the decree "concerns manufacturing procedures only" and that the agency "has not alleged that any of the products currently marketed are defective in any way." The decree is unrelated to Accufix Atrial J Lead, which was subject to a safety alert in December 1994 and which Telectronics no longer produces ("The Gray Sheet" Jan. 2, p. 12)...

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