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Anatomy / Medicine / Cardiac dysrhythmia / Heart diseases / Left bundle branch block / Multicenter Automatic Defibrillator Implantation Trial / New York Heart Association Functional Classification / Heart failure / Implanted cardiac resynchronization device / Cardiac electrophysiology / Circulatory system / Cardiology


Boston Scientific CRT-D Expanded Indications Labeling Supplement PMA P010012/S230, Filed December 11, 2009 Background The following questions Boston Scientific received from the FDA as part of their ongoing review of PMA
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New York / /

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Linde / Boston Scientific / Subgroup / IV Study MERIT HF / Guidant / LBBB Subgroup / /

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United States / /

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pence / /

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FDA Phase / Product Issues / Product Recall / /

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imaging / /

MedicalCondition

mild heart failure / ventricular dysfunction / bundle branch block / left ventricular dysfunction / Pneumothorax / stroke / Diabetes / left bundle branch block / heart failure / future heart failure / /

MedicalTreatment

Cardiac Resynchronization Therapy / /

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FDA / /

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Kim Selzman / Ken Skodacek / Laura Thompson / Heart Failure / /

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team member / Major / representative / General / /

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Product / KS3b3 / KS3b2 / KS3b1 / KS3c / KS3a / SK11 / /

Technology

magnetic resonance imaging / /

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