FDAnews Device Daily Bulletin

ST. JUDE GETS JAPANESE APPROVAL TO MARKET ICDS

Sept. 6, 2005
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St. Jude Medical announced regulatory and reimbursement approvals from the Ministry of Health, Labor and Welfare in Japan for its Epic+ and Atlas+ implantable cardioverter-defibrillator (ICD) product families.

The ICDs will be immediately available in Japan through Getz Brothers, a St. Jude Medical Company, and Fukuda Denshi. The devices are the first St. Jude ICDs available in Japan.

ICDs are medical devices implanted under the skin that are designed to monitor heart rhythms and deliver shocks if dangerous patterns are detected. Engineered to anticipate a wide variety of diagnostic and therapy needs of ICD patients, the St. Jude devices are also designed to make it easier for physicians to manage patients with atrial fibrillation.

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