OPHTHALMIC DEVICES PANEL

One Hundred and Seventh Meeting

Gaithersburg Marriott

Gaithersburg, MD

 

FEBRUARY 5, 2004

 

PUBLIC AGENDA

 

 

9 A.M. – 5:00 P.M.

 

9:00                  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

 

______________________________________________________________________________

 

9:15 – 9:45                                OPEN PUBLIC HEARING

                    _______________________________________________

 

OPEN COMMITTEE SESSION

Jayne S. Weiss, M.D., Chair

 

9:45 – 10:00                                        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 P030028

 

10:00 – 11:30                               SPONSOR PRESENTATION

Followed by

Questions and Answers

 

 

 

 

 

 

11:30 – 12:30pm                                 FDA PRESENTATION

Jeffrey Toy, Ph.D. – Team Leader

Bernard Lepri, O.D., M.S., M.Ed.  – Clinical Reviewer

Gerry W. Gray, Ph.D. – Statistician

 

 

12:30 – 1:30                                                            LUNCH

 

 

1:30 – 5 p.m.                           COMMITTEE DELIBERATIONS

 

Panel Questions for FDA

 

Primary Panel Reviews

 

PANEL DISCUSSION OF PMA P030028

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

 

 

5:00p.m.                                  OPEN MEETING ADJOURNED

 

 

 

 

 

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