The FDA issued a warning letter claiming that St. Jude Medical is breaching the Federal Food, Drug and Cosmetic Act by promoting its Epicor surgical ablation devices for the treatment of atrial fibrillation even though the devices are not approved by the agency for such indication. A spokeswoman for St. Jude Medical said the company "is working diligently to address the points raised in the warning letter and to resolve the FDA's concerns."

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