A meeting of the Circulatory System Devices Panel was held on April 4, 2000.
FDA Staff made a brief presentation on the Least Burdensome provisions of the FDA Modernization Act of 1997.
Subsequently, the committee provided input to the agency regarding the design of clinical trials for the following: 1) devices using spinal cord stimulation in the treatment of angina pectoris; 2) rate-responsive pacemakers, specifically the evaluation of rate-adaptive features; and 3) devices used in the treatment of atrial fibrillation.
Contact: John Stuhlmuller, M.D., at 301-443-8243, x157
Transcripts of this meeting may be purchased from Miller Reporting, 507 C St., N.E., Washington, DC 20002, 202-546-6666 or 1-800-833-7947 (FAX: 202-546-6666) and from the Food and Drug Administration, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857, 301-443-1726.