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In Brief: Telectronics

This article was originally published in The Gray Sheet

Executive Summary

Telectronics: Resumes manufacture and shipment of cardiac pacemakers and pacemaker leads for distribution within the U.S., the firm announces June 21. Telectronics agreed to stop selling its devices in the U.S. in May 1995 under a consent decree signed with FDA that required the firm to make corrections to good manufacturing practices deficiencies at its Miami Lakes, Florida facility ("The Gray Sheet" May 29, I&W-10). Telectronics says it is now in compliance with GMPs...



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