Circulatory Support Devices Panel

9/6/01


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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

Author: spykers