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 / /
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 / /