Food and Drug Administration

Ophthalmic Devices Panel

July 14, 2006

Briefing Information

FDA

FDA Executive Summary (pdf)

Panel Recommendation Options (pdf)

Critical Path Initiative in Medical Devices (pdf)

Condition of Approval Studies: Recent Changes in CDRH (pdf)

FDA Presentation of PMA P050034 (pdf) [added 8/2/06]

VisionCare Ophthalmic Technologies, Inc.

VisionCare Technologies Presentation of PMA P050034: [added 8/2/06]
Review 1 (pdf)
Review 2 (pdf)

Summary of Safety and Effectiveness Data (pdf)

Professional Use Information (pdf)

Patient Information Booklet (pdf)

Surgeon Training (ppt) (htm)

- Added 7/13/06 -

PMA Module 4 Letter (pdf)

IMP-002-LTM Protocol (pdf)

IMT-002 Clinical Report (pdf)

Bibliography (pdf)