510(k) K133481

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) by St. Jude Medical, Inc. — Product Code MXC

K133481 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Inc. for the device "SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)". The FDA issued a decision of Substantially Equivalent on May 28, 2014. The device falls under product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.2800. St. Jude Medical, Inc. has at least 10 other 510(k) clearances on record.