FDA Warns Medtronic Over Heart Rhythm Unit

Law360, New York (November 18, 2009, 4:02 PM EST) -- Medtronic Inc. announced Wednesday that it had received a warning letter from the U.S. Food and Drug Administration regarding an inspection of its heart rhythm device facility over problems the agency found at the unit’s corporate headquarters.

Minneapolis-based Medtronic said the letter related to an August probe conducted at the company’s Cardiac Rhythm Disease Management business, which is based in Mounds View, Minn.

According to Medtronic, the FDA’s observations fall into four general categories: corrective and preventive action and field action timeliness; review and documentation of...
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