Table of Contents
Circulatory Support Devices Panel
FDA Review Team
Device Description
Preclinical Concerns
Sealant Characteristics
Biocompatibility
Sensitization Testing
Sterility
Preclinical Summary
Clinical Studies
US Multi-Center
US Study Population
US Demographics
US Success Data
US Success Data
US Safety Data
European Multi-Center
EU Success Data
European Feasibility
Fevers
Questions for Panel
Question 1
Question 2
Question 2(cont.)
PPT Slide
PPT Slide
PPT Slide
PPT Slide
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Author: spykers
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