FDAnews Device Daily Bulletin

FDA Warns St. Jude Medical

Jan. 16, 2013
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The U.S. Food and Drug Administration has sent a warning letter to St. Jude Medical regarding manufacturing processes at a facility in Southern California, St. Jude and the FDA have confirmed. Until St. Jude corrects the issues that prompted the letter, the FDA will not approve certain types of cardiac rhythm management products from the Little Canada-based medical technology company, the company confirmed Monday. The plant in Sylmar, Calif., is where St. Jude manufactures the Durata defibrillator lead, a wire that connects the defibrillator to the heart.
StarTribune