Advisory Committees
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2012 Meeting Materials of the Ophthalmic Devices Panel
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September 28, 2012 Meeting Materials FDA Generated
Meeting Agenda (PDF - 35KB)Panel Roster (PDF - 13KB)Panel Questions (PDF - 28KB)FDA Executive Summary (PDF - 5.3MB)24- Hour Summary (PDF - 32KB)Voting Questions (PDF - 16KB)FDA Presentation: Beylin and Dahr (PDF - 688KB)FDA Presentation: Lepri and Dahr (PDF - 1.5MB)FDA Presentation: Response to Panel Inquiries (PDF - 132KB)FDA Presentation: Questions for Panel Discussion (PDF - 51KB)Transcripts (PDF - 1.2MB)
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September 28, 2012 Meeting Materials Non-FDA Generated
Sponsor Executive Summary (PDF - 2.1MB)Product Insert (PDF - 346KB)Patient Manual (PDF - 463KB)Surgeon Manual (PDF - 7KB)Device Fitting Manual (PDF - 7KB)Vision Rehabilitation Guide (PDF - 7KB)Clinical Trial Protocol (PDF - 748KB)FLORA (PDF - 7KB)VisQOL (PDF - 105KB)Massof Activity Inventory (PDF - 647KB)Clinical Investigation Report (PDF - 7KB)Safety Tables (PDF - 7KB)Presentation: Second Sight (PDF - 3.5MB)
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