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 IDK211304
510k NumberK211304
Device Name:LINQ II Insertable Cardiac Monitor
ClassificationRecorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Applicant Medtronic, Inc. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactAndrea Artman
CorrespondentAndrea Artman
Medtronic, Inc. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeMXD  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-29
Decision Date2021-05-28

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