01-15590. Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).The meeting will be open to the public.

Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues.

Date and Time: The meeting will be held on July 9, 2001, 10 a.m. to 6 p.m., and July 10, 2001, 8 a.m. to 6 p.m.

Location: Marriott Washingtonian Center, Salons A, B, and C, 9751 Washingtonian Blvd., Gaithersburg, MD.

Contact: 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: On July 9, 2001, the committee will hear brief presentations on issues related to endovascular grafting systems for the treatment of abdominal aortic aneurysms. The committee will then discuss, make recommendations, and vote on a premarket approval application (PMA) for a percutaneous myocardial revascularization system used in the treatment of angina. On July 10, 2001, the committee will discuss, make recommendations, and vote on two separate PMAs for implantable cardiac devices used in the treatment of congestive heart failure.

Background information for each day’s topic, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at http://www.fda.gov/​cdrh/​panelmtg.html. Material for the July 9 meeting will be posted on July 6, 2001; material for the July 10 meeting will be posted on July 9, 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 July 2, 2001. On July 9, 2001, oral presentations from the public will be scheduled between approximately 10:45 a.m. and 11:30 a.m., and near the end of the committee deliberations. On July 10, 2001, oral presentations from the public will be scheduled between approximately 8 a.m. and 8:30 a.m., and between approximately 1:30 p.m. and 2 p.m., and near the end of the committee deliberations on each submission. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 2, 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.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: June 14, 2001.

Linda A. Suydam,

Senior Associate Commissioner.