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Article: EP MedSystems Announces Japanese Regulatory Clearance for EP-4 Computerized Cardiac Stimulator.
- Article from:
- Business Wire
- Article date:
- July 25, 2005
CopyrightCOPYRIGHT 2005 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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WEST BERLIN, N.J. -- EP MedSystems, Inc. (NASDAQ: EPMD), a market leader in electrophysiology products used in cardiac rhythm management, today announced it has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its EP-4(TM) Computerized Cardiac Stimulator. With this clearance, EP MedSystems can now market and distribute the EP-4(TM) in Japan.
Similar to the U.S. Food and Drug Administration (FDA), Japanese law dictates that all medical device manufacturers register their products with the MHLW, which is responsible for maintaining strict quality standards for these products. The Company has already received regulatory ...