OPHTHALMIC DEVICES PANEL

OPEN SESSION

January 17, 2002

9:30 A.M. 5 P.M.

Hilton Washington DC North/Gaithersburg

Salons A, B, and C

620 Perry Parkway

Gaithersburg, MD

9:30 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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9:45 - 10:15 OPEN PUBLIC HEARING

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OPEN COMMITTEE SESSION

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

10:15 - 10:30 BRANCH UPDATES

Donna R. Lochner

Chief, Intraocular and Corneal Implants Branch

PMA P010059

10:30 - 11:30 SPONSOR PRESENTATION

11:30 - 11:45 Panel Questions for the Sponsor

11:45 - 12 Noon FDA PRESENTATION

Donna Lochner Introduction

Joel P. Glover Team Leader

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

12 Noon 12:15 PM Panel Questions for FDA

12:15 - 12:20 Additional Comments From the Sponsor

12:20 - 1:20 LUNCH

1:20 COMMITTEE DELIBERATIONS

Primary Panel Reviewers: Joel Sugar, M.D.

Woodford S. Van Meter, M.D.

PANEL DISCUSSION OF P010059

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

5:00 PM OPEN MEETING ADJOURNED

 

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