Medtronic Unit Reaches Deal With FDA

By Erin Marie Daly

Law360, New York (April 28, 2008, 12:00 AM ET) -- Medtronic Inc. subsidiary Physio-Control said Monday it had brokered a deal with the U.S. Food and Drug Administration over how to improve quality problems related to its external defibrillators more than one year after the company was forced to halt U.S. shipments of the products.

Physio-Control said it had reached an agreement with the FDA on a consent decree that addresses issues raised by the agency during inspections regarding the company’s quality system processes.

The consent decree outlines the actions it must take in order to...
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