OPHTHALMIC DEVICES PANEL

OPEN SESSION

January 18, 2002

8:30 A.M. 3:30 P.M.

Hilton Washington DC North/Gaithersburg

Salons A, B, and C

620 Perry Parkway

Gaithersburg, MD

8:30 AM Call to Order Jayne S. Weiss, M.D. - Acting Chair

Introductory Remarks Sara M. Thornton - Executive Secretary

Conflict of Interest Statement

Appointment to Temporary Voting Status

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8:45 - 9:15 OPEN PUBLIC HEARING

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OPEN COMMITTEE SESSION

Jayne S. Weiss, M.D., Acting Chair

PMA P870024/S043

9:15 - 10:15 SPONSOR PRESENTATION

10:15 - 10:30 Panel Questions for the Sponsor

10:30 - 10:45 FDA PRESENTATION

James Saviola, O.D. Introduction

Eleanor McGhee Team Leader

Bernard L. Lepri, O.D., M.S., M.Ed. - Clinical Reviewer

10:45 - 11:00 Panel Questions for FDA

11:00 - 11:15 Additional Comments From the Sponsor

11: 15 - 11:45 COMMITTEE DELIBERATIONS

Primary Panel Reviewers: Timothy T. McMahon, O.D.

Timothy B. Edrington, O.D.

11:45 - 12:45 LUNCH

12:45 PM PANEL DISCUSSION OF P870024/S043

to include FDA questions to the Panel

30-MINUTE OPEN PUBLIC HEARING SESSION

FDA CLOSING COMMENTS (5 minutes)

SPONSOR CLOSING COMMENTS (5 minutes)

Voting Options Read

PANEL RECOMMENDATION TAKEN BY VOTE

POLLING OF PANEL VOTES

COMMENTS FROM CONSUMER AND INDUSTRY REPRESENTATIVES

FINAL PANEL COMMENTS

3:30 PM OPEN MEETING ADJOURNED

 

NOTE: 15-MIN. BREAKS MAY BE GIVEN AT AN APPROPRIATE TIME DURING THE PROCEEDINGS