FDA Not Satisfied With Medtronic, Inc.'s Response to Warning Letter About Manufacturing Guideline Violations

Medtronic Inc said sales of its heart defibrillators outpaced the global industry but remained weak, disappointing some investors who hoped the company would win more business after a product recall from rival St. Jude Medical Inc. Medtronic, the world’s largest stand-alone maker of medical devices, said the global market for implantable defibrillators, known as ICDs, was beginning to stabilize after several sluggish years due to a weak economy and heightened scrutiny over their use. The devices, which correct irregular heart rhythms, are one of its biggest revenue-generators. Chief Executive Omar Ishrak estimated the total worldwide market for the devices fell 4 percent in the latest quarter. Medtronic performed slightly better, with company defibrillator sales down 3 percent.

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