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510(k) K163008

CareLink SmartSync Device Manager - Pacing System Analyzer by Medtronic, Inc. — Product Code DTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2017
Date Received
October 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pacemaker Electrode Function
Device Class
Class II
Regulation Number
870.3720
Review Panel
CV
Submission Type

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