CareLink SmartSync Device Manager - Pacing System Analyzer

Tester, Pacemaker Electrode Function

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Carelink Smartsync Device Manager - Pacing System Analyzer.

Pre-market Notification Details

Device IDK163008
510k NumberK163008
Device Name:CareLink SmartSync Device Manager - Pacing System Analyzer
ClassificationTester, Pacemaker Electrode Function
Applicant Medtronic, Inc. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactLaura Danielson
CorrespondentLaura Danielson
Medtronic, Inc. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeDTA  
CFR Regulation Number870.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-28
Decision Date2017-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169868540 K163008 000
00643169833753 K163008 000
00643169833739 K163008 000
00643169833715 K163008 000

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