|
|
| Name of Committee | Circulatory System Devices Panel |
| Date and Time | The meeting was held on the following dates:
Oct 22, 02 10:00 AM - 5:30 PM
Oct 23, 02 8:30 AM - 4:30 PM
|
| Location | Holiday Inn, Ballroom
Two Montgomery Village Avenue
Gaithersburg
, 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. Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512625. Please call the Information Line or access this Internet page for up-to-date information on this meeting. |
| Agenda | On October 22, 2002, the committee will discuss, make recommendations, and vote on a premarket approval application for a drug-coated coronary artery stent intended to treat coronary artery obstructions and to help prevent in-stent stenosis. On October 23, 2002, the committee will discuss and make recommendations on a premarket notification (510(k)) submission for an arterial cannula intended to prevent an adverse neurological or limb threatening event. 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 October 22, 2002, session will be posted on October 21, 2002; material for the October 23, 2002, session will be posted on October 22, 2002. |
| 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 October 11, 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 October 11, 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. |
| 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). |
|
