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| Name of Committee | Circulatory System Devices Panel |
| Date and Time | The meeting was held on the following dates:
Mar 4, 02 10:00 AM - 5:00 PM
Mar 5, 02 8:00 AM - 3:00 PM
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| Location | Gaithersburg Marriott Washingtonian Center
Salons A, B, C, and D, 9751 Washingtonian Blvd.
Gaithersburg
, MD |
| Contact Information | Lesley Ewing, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8320, ext. 161, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12625. Please call the Information Line for up-to-date information on this meeting. |
| Agenda | On March 4, 2002, the committee will discuss, make recommendations, and vote on a supplement to a premarket approval application (PMA) for a left ventricular assist device to be used as destination therapy in patients with end stage congestive heart failure. On March 5, 2002, the committee will discuss, make recommendations, and vote on a PMA for an implantable pacemaker/defibrillator used for treatment of both congestive heart failure and life threatening dysrhythmias. Background information for each day’s topic, 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 4, session will be posted on March 1, 2002; material for the March 5 session will be posted on March 4, 2002. |
| Procedure | On March 4, 2002, from 10 a.m. to 4 p.m., and on March 5, 2002, from 8 a.m. to 3 p.m., the meeting is open to the public. 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 February 21, 2002. On both days, oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of each topic and for approximately 30 minutes near the end of the committee deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 21, 2002 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. |
| Closed Committee Information | On March 4, 2002, from 4 p.m. to 5 p.m., the meeting will be closed to permit FDA staff to present to the committee trade secret and/or confidential commercial information regarding pending and future device submissions. This portion of the meeting will be closed to permit discussion of this information (5 U.S.C. 552b(c)(4)). |
| 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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