Physio-Control And FDA Agree On Plan To Address Quality System Issues

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 29 Apr 2008 - 4:00 PDT

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Physio-Control, Inc., a wholly-owned subsidiary of Medtronic, Inc., (NYSE: MDT) 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 on Friday, April 25, 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.

"During the last year, we've made significant investments and improvements to our quality systems and we are pleased to have a plan that formalizes the path to resume full distribution," said Brian Webster, president of Physio-Control. "We have the right people in the organization to execute to the plan and we are working with the FDA to expedite resumption of full operations."

In the meantime, worldwide shipments to meet critical customer requirements and certain specified public health needs will continue.

About Physio-Control

Physio-Control of Redmond, Wash. pioneered defibrillation technology more than 50 years ago. Today, there are over 650,000 LIFEPAK external defibrillators distributed worldwide, making the company the leading provider of external defibrillation technology for saving the lives of people suffering sudden cardiac arrest. For more information, visit http://www.physio-control.com.

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic, Inc.