OPHTHALMIC DEVICES PANEL

 

OPEN SESSION

November 30, 2001

 

9:45A.M. – 4:30 P.M.

 

Holiday Inn Gaithersburg

Walker/Whetstone Rooms

2 Montgomery Village Avenue

Gaithersburg, MD 

 

9:45 AM         Call to Order                                                     Joel Sugar, M.D. - Interim Chair

           

                   Introductory Remarks                                        Sara M. Thornton - Executive Secretary

Conflict of Interest Statement

Appointment to Temporary Voting Status

                        ______________________________________________________

 

9:50 - 10:20                              OPEN PUBLIC HEARING

                   _______________________________________________

 

OPEN COMMITTEE  SESSION

Joel Sugar, M.D., Interim Chair

 

10:20 - 10:35                                    FDA PRESENTATION

                                                                          

10:35 - 10:45                                      DIVISION UPDATE

A. Ralph Rosenthal, M.D.,  Director

Division of Ophthalmic and Ear, Nose, and Throat Devices

 

BRANCH UPDATES

 

Everette T. Beers, Ph.D.

Chief, Diagnostic and Surgical Devices Branch

 

Donna R. Lochner

Chief, Intraocular and Corneal Implants Branch

 

James F. Saviola, O.D.

Chief, Vitreoretinal and Extraocular Devices Branch

 

PMA P010018

 

 

10:45 - 11:45                               SPONSOR PRESENTATION

 

11:45 - 12 Noon                            Panel Questions for the Sponsor

                                    

12 Noon - 1:00 PM                                       LUNCH

 

1:00 - 1:15                                         FDA PRESENTATION

Everette T. Beers, Ph.D. – Introduction

Joel P. Glover – Team Leader

Sheryl L. Berman, M.D. - Clinical Reviewer

 

1:15 – 1:30                                      Panel Questions for FDA

 

1:30 - 1:35                          Additional Comments From the Sponsor

 

1:35                                         COMMITTEE  DELIBERATIONS

Primary Panel Reviewers:            Arthur Bradley, Ph.D.

                                                                                Michael R. Grimmett, M.D.

Jayne S. Weiss, M.D.

 

PANEL  DISCUSSION OF P010018

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

                        

FINAL PANEL COMMENTS

 

4:30 PM                                   OPEN MEETING ADJOURNED

 

 

 

 

 

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