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Quality | 2010.02.20

Physio-Control Resumes Unrestricted Global Shipments of Its LIFEPAK® Defibrillators

REDMOND, Wash.--(BUSINESS WIRE)--Physio-Control Inc., a wholly-owned subsidiary of Medtronic, Inc. (NYSE: MDT), announced today it received notice from the U.S. Food and Drug Administration (FDA) that having successfully met requirements for improvements to the quality system, the company may resume unrestricted worldwide shipments of its external defibrillators. In May 2008, Physio-Control signed a Consent Decree with the FDA to address issues the Agency raised during inspec

 

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