OPHTHALMIC DEVICES PANEL

One Hundred and Eighth Meeting

 

MARCH 5, 2004

 

Hilton Washington DC North/Gaithersburg

620 Perry Parkway, Gaithersburg, MD.

 

9:00 AM      Call to Order                                                  Jayne S. Weiss, M.D. - Chair

 

Introductory Remarks                                                  Conflict of Interest Statement

Sara M. Thornton - Executive Secretary

 

9:10 – 9:15                              BRANCH UPDATES

Karen F. Warburton, M.S.

Microbiologist, Vitreoretinal and Extraocular Devices Branch

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9:15 – 10:15                 OPEN COMMITTEE SESSION

Jayne S. Weiss, M.D., Chair

 

GENERAL ISSUES DISCUSSION

 

FDA TEAM PRESENTATION

 

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

Joseph N. Blustein, M.D., - Medical Officer

Don Calogero, M.S.

Gene N. Hilmantel, O.D., M.S.

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10:15 - 10:45           OPEN PUBLIC HEARING SESSION

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10:45 – 12 NOON                       PANEL DELIBERATIONS

 

12:00-1:00                                                   LUNCH

 

1:00 – 3:15                               PANEL DELIBERATIONS (continued)

 

                                        SECOND OPEN PUBLIC HEARING SESSION*

 

3:45 – 4:00                       PANEL DISCUSION ON REMAINING ISSUES

 

4:00 PM                                   OPEN MEETING ADJOURNED

 

* The meeting will be open for public comments throughout the afternoon.

 

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