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CDRH Advisory Meeting Materials Archive

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Name of CommitteeGastroenterology and Urology Devices Panel
Date and TimeThe meeting was held on the following dates:
Jan 17, 03 8:30 AM - 5:00 PM
LocationHilton Washington DC North/Gaithersburg, Salon A, B, and C
620 Perry Parkway
Gaithersburg , MD
Contact InformationJeffrey Cooper, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD, 20850, 301-594-1220, ext. 121. Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512523. Please call the Information Line or access this Internet page for up-to-date information on this meeting.
AgendaThe committee will discuss, make recommendations, and vote on a premarket approval application for a device for the treatment of gastroesophageal reflux disease. Background information, including the agenda and questions for the committee, will be available to the public one business day before the meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material will be posted on January 16, 2003.
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 by January 8, 2003. Oral presentations from the public will be scheduled between approximately 8:45 a.m. and 9:15 a.m., and between approximately 3 p.m. and 3:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before January 8, 2003, 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. 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: PDF
Agenda: Word
Briefing: Text
Minutes: Text
Roster: PDF
Summary: Text
Transcript: Text
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
 
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