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| Name of Committee | Circulatory System Devices Panel |
| Date and Time | The meeting was held on the following dates:
Sep 10, 01 9:00 AM - 6:00 PM
Sep 11, 01 9:00 AM - 5:00 PM
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| Location | Gaithersburg Marriott, Salons D, E and F
9751 Washingtonian Blvd
Gaithersburg
, MD |
| Contact Information | Megan Moynahan, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517, ext. 171, 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 | Note: The meeting adjourned early on 9/11/01 due to national security events in Washington DC. On September 10, 2001, the committee will discuss, make recommendations, and vote on two premarket approval applications (PMA’s) for septal occluders. On September 11, 2001, the committee will discuss, make recommendations, and vote on two PMA’s, one for a surgical sealant and one for a biological glue. 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 September 10 meeting will be posted on September 7, 2001; material for the September 11 meeting will be posted on September 10, 2001. |
| 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 August 31, 2001. 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 August 31, 2001, 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. |
| 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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