PMA (premarket approval) for Medtronic' second-generation implantable defibrillator:
This article was originally published in Clinica
Medtronic has received premarket approval from the US FDA to market its GEM II DR (model 7273) dual chamber defibrillator. With a volume of 40cm3, this second generation product is 35% smaller than the GEM DR and is has an energy output of 30 joules. It combines the function of defibrillators and rate-responsive pacemakers, capable of discriminating between fast, life-threatening ventricular rhythms and harmless atrial arrhythmias.
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