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Medical equipment / Implants / Interventional cardiology / Prosthetics / Ventricular assist device / Blood pump / Medical device / Food and Drug Administration / Heart failure / Medicine / Anatomy / Cardiology


Berlin Heart, Inc. EXCOR® Pediatric Ventricular Assist Device HDE H100004 Panel Package – Sponsor Executive Summary Berlin Heart, Inc. EXCOR Pediatric Ventricular Assist Device ®
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City

Berlin / Houston / /

Company

73 Berlin Heart Inc. / MicroMed Technology Inc. / Sponsor Executive Summary Berlin Heart Inc. / Berlin Heart Inc. / Historical Control Group / Circulatory System Devices Panel Berlin Heart Inc. / Testing Laboratory / /

Country

Germany / United States / Canada / /

Event

FDA Phase / /

Facility

Laboratory Values / /

IndustryTerm

therapy for adults with advanced heart failure / pediatric ventricular assist device / comparable pediatric device / clinical protocol / study protocol / continued access protocol / pulsatile ventricular assist device / control / /

MedicalCondition

disease / biventricular dysfunction / stroke / Alternative Practices Systolic heart failure / Major Infection SAE / injury / heart failure / advanced heart failure / Irritation / illness / /

MedicalTreatment

ECMO / clinical protocol / cannulas / cannula / extracorporeal membrane oxygenation / /

Organization

office of Orphan Product Development / Food and Drug Administration / Center for Devices and Radiological Health / Ikus Driving Unit / FDA / European Union / Division of Cardiovascular Devices / /

Position

Executive / Major / /

Product

Pediatric Ventricular Assist Device / History The EXCOR® Pediatric / DeBakey VAD® Child / /

Technology

study protocol / clinical protocol / continued access protocol / transplantation / /

SocialTag