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
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