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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Guidant ICDs: Three deaths have now been associated with clinical failures of Guidant's Contak Renewal and Renewal 2 implantable cardioverter defibrillators that were manufactured on or before Aug. 26, 2004, according an 1Oct. 13 Preliminary Public Health Notification from FDA. The notice updates a July 14 agency communication about malfunctions with the Renewal products as well as the Ventak Prizm 2 ICDs, which led to a Class I recall (2"The Gray Sheet" June 20, 2005, p. 19). Guidant has reported a total of 49 instances of these ICDs exhibiting the specified failure mode...

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