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St. Jude Medical, Cardiac Rhythm Management Divisi
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SJM CONFIRM IMPLANTABLE CARDIAC MONITOR is an FDA 510(k)-cleared medical device (K122090) manufactured by St. Jude Medical, Cardiac Rhythm Management Divisi. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 2012. Regulation: 8.