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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeCirculatory System Devices Panel
Date and TimeThe meeting was held on the following dates:
Dec 7, 06 8:00 AM - 5:30 PM
Dec 8, 06 8:00 AM - 5:30 PM
LocationHilton Washington DC North/Gaithersburg, Salons A, B, C, D and E
620 Perry Parkway
Gaithersburg , MD
Contact InformationJames Swink, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8262, ext. 163, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512625. Please call the Information Line for up-to-date information on this meeting.
AgendaThe committee will discuss and make recommendations regarding issues related to stent thrombosis in coronary drug-eluting stents. Background information for the topic, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at http://www.fda.gov/cdrh/panel (click on Upcoming CDRH Advisory Panel/Committee Meetings).
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 November 15, 2006. Oral presentations from the public will be scheduled on both days for approximately 1 hour at the beginning of committee deliberations and for approximately 1 hour near the end of the deliberations. Time allotted for each presentation may be limited. 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 November 15, 2006.
 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:December 7, 2006 MeetingPDF
Agenda:December 8, 2006 MeetingPDF
Brief Summary:December 7 - 8, 2006 MeetingText
Briefing:December 7 - 8, 2006 MeetingText
Minutes:Final Minutes for December 7, 2006 MeetingPDF
Minutes:Final Minutes for December 8, 2006 MeetingPDF
Notice of Meeting:December 7 - 8, 2006 MeetingText
Other:Nature and Basis Statements of Conflict(s) of Interest Text
Other:Consumer Qs&As on Drug-Eluting StentsText
Questions:December 7 - 8, 2006 MeetingPDF
Roster:December 7 - 8, 2006 MeetingPDF
Slides:December 7, 2006 MeetingText
Slides:December 8, 2006 MeetingText
Transcript:December 8, 2006 MeetingRich Text Format
Transcript:December 7, 2006 MeetingRich Text Format
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
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