MINNEAPOLIS--(BUSINESS WIRE)--Physio-Control, Inc., a wholly-owned subsidiary of Medtronic, Inc., (NYSE: MDT) today announced that it has reached an agreement on a consent decree with the U.S. Food and Drug Administration (FDA) regarding its quality system improvements for its external defibrillator products. The agreement was filed Friday, April 25th in the U.S. District Court for the Western District of Washington and is subject to that court’s approval. The agreement addresses issues raised by the FDA during inspections regarding the company’s quality system processes and outlines the actions Physio-Control must take in order to resume unrestricted distribution of its external defibrillators.
