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City Paul / / Company Boston Scientific Corporation / Design Location Guidant Corporation / GUIDANT Corporation / PRM Software / Cashel Road Clonmel / Guidant Ireland / Cardiac Rhythm Management 4100 Hamline Avenue North / / Continent Europe / / Country Germany / Switzerland / Venezuela / Netherlands / Saudi Arabia / Italy / Slovenia / Sweden / Kuwait / South Africa / New Zealand / Chile / Guadeloupe / Norway / Thailand / Indonesia / Belgium / Turkey / France / Malaysia / Jordan / Austria / United States / Martinique / Guyana / Iceland / Dominican Republic / Canada / Australia / Portugal / Liechtenstein / United Kingdom / Singapore / Israel / New Caledonia / Luxembourg / Finland / Lebanon / Spain / Greece / India / Ireland / Denmark / Czech Republic / / Currency pence / / / Event FDA Phase / / IndustryTerm therapy for heart failure / electronic devices / investigational device / high-energy shocks / / MedicalCondition Mild heart failure / Chest pain / Pneumothorax / Pericardial effusion / bradyarrhythmias / Syncope / Fatigue / tachycardia / PG case Bradycardia / severe heart failure / hypertension / sudden cardiac death / Dyspnea / AV block / Myocardial infarction / heart failure / Pleural effusion / ventricular fibrillation / Infection / Asymptomatic heart failure / Dizziness / Renal failure / / MedicalTreatment cardiac surgery / Cardiac Resynchronization Therapy / cardioversion / Alternative therapies / / Organization International Organization for Standardization / FDA / / Person Dan Flaig / / / Position GENERAL INFORMATION Type / SUBMISSION OVERVIEW GENERAL INFORMATION Device Generic Name / Physician / GENERAL INFORMATION COGNIS / GENERAL INFORMATION Manufacturing Location / Conductor / / Product TRIAD / S165 / P9010012 / S031 / H210 / H170 / Non-HF Related Events Supplement / P010012 / 13Jun2003 / LIVIAN / / ProvinceOrState Vermont / Minnesota / / TVStation Wand / / Technology AV / / SocialTag 
SECTION 1. GENERAL INFORMATION[removed].