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