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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
510(k) Number K133481
Device Name SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
Applicant
St. Jude Medical, Inc.
645 Almanor Ave.
Sunnyvale,  CA  94085 -2927
Applicant Contact Michael McSweeney
Correspondent
St. Jude Medical, Inc.
645 Almanor Ave.
Sunnyvale,  CA  94085 -2927
Correspondent Contact Michael McSweeney
Regulation Number870.2800
Classification Product Code
MXC  
Date Received11/13/2013
Decision Date 05/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00746564
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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