FDA Summary

9/6/01


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Table of Contents

FDA Summary

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Proposed Indications for Use

Clinical Data Sets

Pivotal Cohorts - ASD

Patient Outcome Assessment

ASD - Effectiveness

ASD - Safety

Pivotal Cohort - Fenestrated Fontan

Patient Outcome Assessment

Fenestrated Fontan - Effectiveness

Fenestrated Fontan - Safety

Panel Questions

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Author: spykers