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Approval for the lumax implantable cardioverter defibrillators (icds), models 300 vr, 340 vr, 300 vr-t, 340 vr-t, 300 dr, 340 dr, 300 dr-t, 340 dr-t, 300 hf, 340 hf, 300 hf-t and 340 hf-t and programmer software version 603.u for use with the lumax family of icds and biotronik, inc. pacers, single chamber icds and dual chamber icds. The device, as modified, will be marketed under the trade name lumax, and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and/or for providing treatment of congestive heart failure.
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