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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeOphthalmic Devices Panel
Date and TimeThe meeting was held on the following dates:
Apr 24, 2008 8:30 AM - 5:00 PM
Apr 25, 2008 8:30 AM - 5:00 PM
LocationGaithersburg Holiday Inn, Ballroom
2 Montgomery Village Ave.
Gaithersburg , MD
Contact InformationKaren F. Warburton, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, (240) 276-4238, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512396. Please call the Information Line for up-to-date information on this meeting. A notice in the FEDERAL REGISTER about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
AgendaOn April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMT™). The IMT™, a visual prosthetic device, is indicated for monocular implant in patients with stable, moderate to profound central vision impairment due to bilateral central scotomas associated with end-stage macular degeneration with geographic atrophy or disciform scar, foveal involvement and cataract. On April 25, 2008, the committee will discuss general issues concerning the post market experience with phakic intraocular lenses and laser-assisted in situ keratomileusis (LASIK). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link.
ProcedureInterested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before April 15, 2008. Oral presentations from the public will be scheduled on April 24, 2008, between approximately 9:30 a.m. and 10 a.m. and between approximately 3:30 p.m. and 4 p.m.; and on April 25, 2008 between approximately 10 a.m. and 11:15 a.m. and between approximately 3 p.m. and 4 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 7, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 8, 2008.
 Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
ConductFDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings.
Related Documents
Agenda:Draft Agenda for April 25, 2008 Meeting PDF
Brief Summary:Ophthalmic Devices Panel Meeting Summary - April 25, 2008Text
Briefing:Briefing for April 25, 2008 Meeting Text
Minutes:Minutes for April 25, 2008 Meeting Text
Other:Waivers for Conflicts of Interest for April 24 & 25, 2008 MeetingText
Questions:Draft Questions for April 25, 2008 MeetingText
Roster:Draft Roster for April 25, 2008 Meeting PDF
Slides:Slides for April 25, 2008 Meeting Text
Transcript:Transcript for April 25, 2008 Meeting: Part1PDF
Transcript:Transcript for April 25, 2008 Meeting: Part 2PDF
Transcript:Transcript for April 25, 2008 Meeting: Part 3PDF
Transcript:Transcript for April 25, 2008 Meeting: Part 4PDF
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).