SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) is an FDA 510(k)-cleared medical device (K133481) manufactured by St. Jude Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 27, 2014. Regulation: 8.