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Company VF / CRT ON / CRT OFF / Medtronic Inc. / / Continent Europe / / Country United States / Canada / / Currency pence / / Event FDA Phase / Natural Disaster / / Facility University of Ottawa Heart Institute-sponsored / Hospital Discharge Pre-Hospital Discharge Blinded Follow-up / / IndustryTerm medical management / hardware/software / therapy for heart failure / / MedicalCondition severe heart failure / nerve stimulation myocardial irritability pericardial effusion pneumothorax / embolism tissue necrosis / bradycardia pacing therapies / mild heart failure / reaction cardiac perforation chronic nerve damage death endocarditis / vEntricular dysfunction / threshold elevation thrombosis / bundle branch block / atrial tachyarrhythmia therapies / cysts / nonischemic heart failure / ischemic heart failure / bradyarrhythmias / constrictive pericarditis / atrial tachyarrhythmias / ventricular tachyarrhythmia therapies / ventricular tachyarrhythmias / cardiac dissection cardiac tamponade / vein wall rupture infection / embolism / heart failure / heart block hemothorax keloid / tachyarrhythmias / rate-responsive bradycardia pacing / phantom shock / / MedicalTreatment Cardiac Resynchronization Therapy / cardioversion / / Organization New York Heart Association / U.S. Food and Drug Administration / FDA / University of Ottawa Heart Institute-sponsored / / Position GENERAL INFORMATION Device Generic Name / / Product D274TRK / CRT-D / P010031 / S084 / D284TRK / S232 / C154DWK / D224TRK / D334TRG / D314TRG / S171 / / ProvinceOrState Minnesota / /
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Microsoft Word - 25Oct11 Proposed Summary of Safety and Effectiveness Document.doc