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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Pacemaker Electrode Function
510(k) Number K163008
Device Name CareLink SmartSync Device Manager - Pacing System Analyzer
Applicant
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Applicant Contact Laura Danielson
Correspondent
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Correspondent Contact Laura Danielson
Regulation Number870.3720
Classification Product Code
DTA  
Subsequent Product Code
DTC  
Date Received10/28/2016
Decision Date 02/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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