FDA Summary

9/6/01


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Table of Contents

FDA Summary

PPT Slide

FDA Review Team

Regulatory History

Regulatory History

Regulatory History

BioGlue Indication

PPT Slide

PPT Slide

Entrance Criteria

Indication for Surgery Anastomotic Location

Clinical Summary

Clinical Summary

Effectiveness Results Primary Endpoint

Effectiveness Results Secondary Endpoints

Effectiveness Results Secondary Endpoints

Major Safety Results

Major Safety Results

Preclinical Data and Discussion Items

Summary of Non-Clinical Testing

Summary of Non-Clinical Testing

Results of Non-Clinical Immunogenicity Testing

Independent Review Henry Homburger, M.D. Section of Clinical Chemistry and Medical Labs, Mayo Clinic

Independent Review Henry Homburger, M.D. Section of Clinical Chemistry and Medical Labs, Mayo Clinic

Independent Review Henry Homburger, M.D. Section of Clinical Chemistry and Medical Labs, Mayo Clinic

Panel Questions

PPT Slide

PPT Slide

PPT Slide

PPT Slide

PPT Slide

PPT Slide

Panel Questions-Labeling

Panel Questions-Labeling

Author: spykers