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Healthcare Industry News:  defibrillator 

Devices Cardiology FDA

 News Release - April 28, 2008

Physio-Control and FDA Agree on Plan to Address Quality System Issues

MINNEAPOLIS--(HSMN NewsFeed)--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.


“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 www.physio-control.com.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.

Source: Medtronic

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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