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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:
Mar 18, 2009 8:00 AM - 5:30 PM
LocationHilton Washington DC North/Gaithersburg, Salons A, B and C
620 Perry Pkwy.
Gaithersburg , MD
Contact InformationJames Swink, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4050, 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. 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 TherOx, Inc., for the TherOx Aqueous Oxygen System (AO System). The system is intended for use in acute myocardial infarction (AMI) patients, who have undergone successful revascularization less than or equal to 6 hours from symptom onset. These patients are then randomized to AO Therapy or not. The endpoint is reduction in the final size of the infarct. The system draws blood from the patient, hyperoxygenates it with the AO cartridge component of the system, and reinfuses the blood via the infusion catheter directly to the infarction site of the heart. This therapy is intended to be performed for 90 minutes post percutaneous coronary intervention/stenting. 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 March 4, 2009. Oral presentations from the public will be scheduled approximately 30 minutes at the beginning of committee deliberations and approximately 30 minutes near the end of the deliberations. 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 February 25, 2009. 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 February 26, 2009.
 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 AgendaPDF
Brief Summary:Brief SummaryText
Presentations:Presentation SlidesText
Roster:Draft RosterPDF
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).