LINQ II Insertable Cardiac Monitor

Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Linq Ii Insertable Cardiac Monitor.

Pre-market Notification Details

Device IDK221962
510k NumberK221962
Device Name:LINQ II Insertable Cardiac Monitor
ClassificationRecorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Applicant Medtronic, Inc. 8200 Coral Sea Street NE MS-MVS11 Mounds View,  MN  55112
ContactDianna L. Johannson
CorrespondentDianna L. Johannson
Medtronic, Inc. 8200 Coral Sea Street NE MS-MVS11 Mounds View,  MN  55112
Product CodeMXD  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-05
Decision Date2022-08-25

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