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Medtronic

This article was originally published in The Gray Sheet

Executive Summary

Launches the GEM DR model 7271 full-featured, dual chamber, rate responsive pacemaker/defibrillator system in Europe. The device incorporates Active Can technology as well as Medtronic's PR Logic dual chamber detection algorithm to discriminate between fast ventricular rhythms that are life-threatening and fast atrial arrhythmias that are not. At 62 cc, the 35 joule GEM DR is the world's smallest defibrillator and is anticipated to last seven to nine years under typical use conditions. A May 8 premarket approval application submission is pending at FDA for the device

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