UPDATE 1-US FDA warns St. Jude on heart device claims

Tue May 18, 2010 10:53am EDT

* Claims for two heart devices draw objections

* Company says working to address FDA concerns

WASHINGTON May 18 (Reuters) - Device maker St Jude Medical Inc (STJ.N) made improper claims about two heart devices, U.S. regulators said in a letter to the company.

The Food and Drug Administration, in an April 23 letter, objected to statements made on a company website about the Epicor LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device.

St. Jude spokeswoman Marisa Bluestone said the company is "working diligently to address the points raised in the warning letter and to resolve the FDA's concerns."

The FDA posted the letter on Tuesday here. (Reporting by Lisa Richwine, editing by Gerald E. McCormick) ((lisa.richwine@thomsonreuters.com; + 1 202 310 5691; www.twitter.com/ReutersLisaRx))

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