Physio-Control Receives FDA 510(K) Clearance For LIFEPAK(R) 15 Monitor/Defibrillator

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 29 Mar 2009 - 0:00 PDT

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Physio-Control, Inc., a wholly owned subsidiary of Medtronic, Inc., (NYSE: MDT) announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to market the LIFEPAK 15 monitor/defibrillator within the United States. Official notification of the FDA 510(k) Premarket Notification was posted to the FDA website on March 16, 2009, and can be viewed here.

"With the LIFEPAK 15 monitor/defibrillator, Physio-Control is delivering on its commitment to provide innovative, reliable and durable equipment to emergency personnel so they can focus on the most important task at hand - saving lives," said Brian Webster, president of Physio-Control. "This industry was built on the innovations delivered by Physio-Control and the LIFEPAK 15 monitor continues to define the new standard for emergency care products."

About Physio-Control

Physio-Control, a division of Medtronic, is located in Redmond, Wash. Physio-Control pioneered defibrillation technology more than 50 years ago. With nearly 700,000 LIFEPAK® defibrillators distributed worldwide, the company is the world's leading provider of external defibrillation and monitoring technology for the treatment of sudden cardiac arrest and other cardio-respiratory emergencies. To find out more about Physio-Control, go to www.physio-control.com or call 1-800-442-1142.

Physio-Control entered into a consent decree with the FDA in May, 2008. The decree currently places restrictions on the type and amount of products which may be shipped until improvements to the company's quality system have been confirmed. In the interim, Physio is able to ship a limited selection of product to meet customer needs.

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.

Source
Medtronic

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