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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeMedical Devices Dispute Resolution Panel
Date and TimeThe meeting was held on the following dates:
Apr 19, 2007 8:30 AM - 5:30 PM
LocationHoliday Inn, Ballroom
Two Montgomery Village Ave.
Gaithersburg , MD
Contact InformationNancy Collazo-Braier, HFZ-1, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3959, nancy.braier@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014510232. Please call the Information Line for up-to-date information on this meeting.
AgendaThe committee will discuss, make recommendations, and vote regarding a scientific dispute between the agency and Cardima Inc. related to the not-approvable determination for the premarket approval application (PMA) for the REVELATION® Tx Microcatheter with NavAblator Ablation System, indicated for the treatment of drug refractory paroxysmal atrial fibrillation. 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 2007 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 12, 2007. Oral presentations from the public will be scheduled between approximately 9 a.m. and 9:30 a.m. and between approximately 1:30 p.m. and 2 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 4, 2007. 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 5, 2007.
 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 19, 2007 Meeting PDF
Brief Summary:Summary of the Medical Device Dispute Resolution Panel Meeting - April 19, 2007Text
Briefing:Briefing Information for April 19, 2007 Meeting Text
Minutes:Minutes for April 19, 2007 MeetingPDF
Other:Nature and Basis Statements of Conflict(s) of InterestText
Questions:Questions for April 19, 2007 Meeting PDF
Roster:Draft Roster for April 19, 2007 Meeting PDF
Transcript:Transcript for April 19, 2007 MeetingPDF
Transcript:Transcript for April 19, 2007 MeetingPDF
Transcript:Transcript for April 19, 2007 MeetingPDF
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).