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| Name of Committee | Circulatory System Devices Panel |
| Date and Time | The meeting was held on the following dates:
Mar 17, 04 9:00 AM - 5:00 PM
Mar 18, 04 9:00 AM - 5:00 PM
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| Location | Hilton Washington DC North/Gaithersburg, Salons A, B, and C,
620 Perry Parkway
Rockville
, MD |
| Contact Information | Geretta Wood, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8320, ext. 143, 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. |
| Agenda | On March 17, 2004, the committee will discuss, make recommendations, and vote on a premarket approval application for a Total Artificial Heart indicated for bridge to transplant usage in cardiac transplant-eligible candidates at risk of imminent death from non-reversible biventricular failure and replaces the patient’s native ventricles and valves. The device is intended for use inside the hospital. On March 18, 2004, FDA will present to the committee the history, current medical practice, and regulatory background regarding Aortic Anastomotic Devices. The committee will discuss and make recommendations regarding the type of data and study required to effectively evaluate performance of Aortic Anastomotic Devices for marketing, recognizing the significant public health impact on cardiac disease they represent. Background information for the topics, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the March 17 session will be posted on March 16, 2004; material for the March 18 session will be posted on March 17, 2004. |
| Procedure | Interested 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 by March 8, 2004. On March 17, 2004, oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations and for approximately 30 minutes near the end of the deliberations. On March 18, 2004, oral presentations from the public will be scheduled from approximately 10 a.m. to 12:30 p.m. and for approximately 30 minutes 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 before March 8, 2004, 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. |
| | Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. |
| Conduct | FDA 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 | |
| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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