FDA WARNING_LETTER - St. Jude Medical Atrial Fibrillation Division Inc. - July 29, 2009

During a July 2009 inspection and website review, the FDA found St. Jude Medical Atrial Fibrillation Division Inc. was promoting and marketing the Epicor LP Cardiac Ablation System and Epicor UltraCinch LP Ablation Device in the U.S. in violation of the Federal Food, Drug, and Cosmetic Act.

The FDA had cleared the Epicor LP Cardiac Ablation System (K080292) for cardiac tissue ablation during surgery and approved an IDE (G060036) for a clinical study on atrial fibrillation treatment. However, the firm's website and promotional materials (CD, brochure, spec sheet) made claims like creating "Cox Maze III lesions" or a "classic box lesion," which the FDA considers synonymous with atrial fibrillation treatment.

These claims constitute promotion of an investigational device for an unapproved use, violating 21 CFR 812.7(a) and 812.7(d) by representing the device as safe or effective for unapproved purposes. This renders the investigational devices adulterated under section 501(i) of the Act and is a prohibited act under section 301(q).

Furthermore, the firm was marketing these devices as "commercially available for use in the United States" for atrial fibrillation treatment without marketing clearance or approval, a major change in intended use (21 CFR 807.81