OPHTHALMIC DEVICES PANEL

One Hundred and Sixth Meeting

 

AGENDA

 

OCTOBER 3, 2003

 

8:30 A.M. 4:00 P.M.

 

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

Introductory Remarks Sara M. Thornton - Executive Secretary

Conflict of Interest Statement

Appointment to Temporary Voting Status

 

FDA Presentation ______________________________________________________________________________

 

8:45 - 9:15 OPEN PUBLIC HEARING

_______________________________________________

 

OPEN COMMITTEE SESSION

Jayne S. Weiss, M.D., Chair

 

9:15 - 9:30 DIVISION UPDATE

A. Ralph Rosenthal, M.D., Director

 

BRANCH UPDATES

James F. Saviola, O.D.

Chief, Vitreoretinal and Extraocular Devices Branch

Donna R. Lochner

Chief, Intraocular and Corneal Implants Branch

Everette T. Beers, Ph.D.

Chief, Diagnostic and Surgical Devices Branch

 

PMA P030016

 

9:30 - 10:30 SPONSOR PRESENTATION

 

10:30 - 11:00 Panel Questions for the Sponsor

 


 

 

11:00 - 11:20 FDA PRESENTATION

Donna Lochner Introduction

Kesia Y. Alexander, Ph.D. Team Leader

Malvina B. Eydelman, M.D. - Medical Officer

Gerry Gray, Ph.D. - Statistician

 

11:20 - 11:30 Panel Questions for FDA

 

11:30 - 11:35 Additional Comments from the Sponsor

 

11:35 - 12:35 LUNCH

 

12:35 4:00 p.m. COMMITTEE DELIBERATIONS

 

Primary Panel Reviewers:

 

Dr. Marian S. Macsai-Kaplan

Dr. Joel Sugar

Dr. Michael R. Grimmett

 

PANEL DISCUSSION OF PMA P030016

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

 

4:00p.m. OPEN MEETING ADJOURNED

 

 

 

 

 

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