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Boston Scientific ICDs

This article was originally published in The Gray Sheet

Executive Summary

Firm resumes shipments of its Livian and Renewal cardiac resynchronization therapy defibrillators and Confient, Prizm and Vitality implantable cardioverter defibrillators after receiving FDA approval for previously unauthorized manufacturing process changes, Boston Scientific announces May 21. On March 15, the firm pulled all ICDs and CRT-Ds from U.S. shelves because manufacturing changes were made without prior FDA authorization. The firm resumed shipments of Teligen ICDs and Cognis CRT-Ds in April with FDA's go-ahead (1"The Gray Sheet" April 19, 2010)
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