2016 Materials of the Gastroenterology-Urology Devices Panel

February 25, 2016: Meeting Materials FDA Generated

• Agenda: Feb. 25, 2016
• Roster: Feb. 25, 2016
• Panel and Voting Questions: Feb. 25, 2016
• FDA Executive Summary: Feb. 25, 2016
• Bibliography for FDA’s Advisory Panel Presentation: Feb. 25, 2016
• 24 Hour Summary: Feb. 25, 2016
• Introductory Presentation (T. Valdes): Feb. 25, 2016
• Clinical Presentation (C. Long): Feb. 25, 2016
• Clinical Presentation (M. Golding): Feb. 25, 2016
• PAS Presentation (M. Bayona): Feb. 25, 2016
• Statistical Presentation (LM. Dong): Feb. 25, 2016
• Transcipt: Feb. 25, 2016

February 26, 2016: Meeting Materials FDA Generated

• Agenda: Feb. 26, 2016
• Roster: Feb. 26, 2016
• Panel Questions (LKX): Feb. 26, 2016
• Panel Questions (LRL): Feb. 26, 2016
• Panel Questions (LKN): Feb. 26, 2016
• FDA Questions (Reclassification of Urogynecologic Surgical Mesh Instrumentation): Feb. 26, 2016
• FDA Executive Summary (LKN): Feb. 26, 2016
• FDA Executive Summary (Reclassification of Urogynecologic Surgical Mesh Instrumentation): Feb. 26, 2016
• FDA Executive Summary (LKX/ LRL): Feb. 26, 2016
• Bibliography for FDA’s Advisory Panel Presentation: Feb. 26, 2016
• 24 Hour Summary: Feb. 26, 2016
• Presentation (Device Classification): Feb. 26, 2016
• Presentation (LKN): Feb. 26, 2016
• Presentation (LKN Questions): Feb. 26, 2016
• Presentation (LKX-LRL): Feb. 26, 2016
• Presentation (LRL-LKX Questions): Feb. 26, 2016
• Presentation (Reclassification of Urogynecologic Surgical Mesh Instrumentation): Feb. 26, 2016
• Presentation (FDA Questions-Reclassification of Urogynecologic Surgical Mesh Instrumentation): Feb. 26, 2016
• Transcipt: Feb. 26, 2016

February 25-26, 2016: Meeting Materials Non-FDA Generated

• Sponsor Executive Summary (TOPAS): Feb. 25, 2016
• Presentation: ASTORA Womens Health