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U.S. Department of Health and Human Services

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:
Jun 25, 2008 8:00 AM - 5:00 PM
LocationHilton Washington DC North/Gaithersburg, Salons 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, 240-276-4151 or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512523. 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.
AgendaThe committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Medical Enterprises, Ltd., for a drug/device combination product designed to prevent recurrence of bladder cancer. Synergo SB-TS 101.1 Device with Mitomycin C is indicated for use for prophylactic treatment of recurrence in patients following endoscopic removal of Ta-T1 and G1-3 superficial transitional cell carcinoma of the bladder (STCCB). Ta-T1 refers to the stage of the tumor, which is a measure of how deep the tumor penetrates into the bladder wall, with Ta and T1 being the most superficial stages for raised bladder tumors. G1-3 refers to the tumor grade, which is a measure of how aggressive the tumor is likely to grow, with G1 being the least aggressive, and G3 the most. Synergo and Mitomycin C treatment is clinically indicated for STCCB patients of intermediate and high risk. 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 June 16, 2008. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 8:45 a.m., and between approximately 2:45 p.m. and 3:15 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 June 6, 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 June 9, 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 June 25, 2008PDF
Brief Summary:June 25, 2008Text
Briefing:Briefing Information for June 25, 2008 MeetingText
Questions:Questions for June 25, 2008 Meeting Text
Roster:Draft Update Roster for June 25, 2008 MeetingPDF
Roster:Final Roster for June 25, 2008 MeetingPDF
Transcript:Transcript for June 25, 2008 Meeting: Part 1PDF
Transcript:Transcript for June 25, 2008 Meeting: Part 2PDF
Transcript:Transcript for June 25, 2008 Meeting: Part 3PDF
Transcript:Transcript for June 25, 2008 Meeting: Part 4PDF
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
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