03-19172. Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Cancellation

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The meeting of the Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee scheduled for August 20, 2003, is cancelled based upon a decision by the sponsor, CardioGenesis Corp. to submit additional information for FDA review in support of their premarket approval application for the Axcis Percutaneous Myocardial Revascularization. This meeting was announced in the Federal Register of July 21, 2003 (68 FR 43133).

FOR FURTHER INFORMATION CONTACT:

Les Weinstein, Center for Devices and Radiological Health (HFZ-5), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-7991, FAX [phone], [e-mail], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 10232.

Dated: July 23, 2003.

Peter J. Pitts,

Associate Commissioner for External Relations.