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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:
Dec 15, 2006 8:00 AM - 5:00 PM
LocationHilton Washington DC North/Gaithersburg, Salons A, B and C,
620 Perry Parkway
Gaithersburg , MD
Contact InformationNancy Collazo-Braier, HFZ-1, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-7967, 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 Acorn Corporation related to the approvability of a premarket approval application for the CorCap Cardiac Support Device for patients with dilated cardiomyopathy. Background information for the topic, including the attendee list, 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 December 1, 2006. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 8:45 a.m. and between approximately 1 p.m. and 1:30 p.m. on December 15, 2006. 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 December 1, 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 15, 2006 MeetingPDF
Briefing:December 15, 2006 MeetingText
Minutes:Minutes for December 15, 2006 Meeting (Corrected)Text
Notice of Meeting:December 15, 2006 MeetingText
Other:Nature and Basis Statements of Conflicts(s) of Interest for December 15, 2006 MeetingText
Other:Amendment to Notice of Meeting for December 15, 2006 Text
Questions:December 15, 2006 MeetingPDF
Roster:December 15, 2006 MeetingPDF
Slides:December 15, 2006 MeetingText
Summary:December 15, 2006 MeetingText
Transcript:December 15, 2006 MeetingRich Text Format
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).