Devices · Medtronic, Inc.

LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application

Medtronic, Inc. is listed for LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (K230553). The FDA list gives April 26, 2023 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MXD. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230553

Official FDA database record

Date of final decision

April 26, 2023

Company on the FDA list

Medtronic, Inc.

Lead panel

Cardiovascular

Primary product code

MXD

openFDA device name for the code

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

Device class

2

Regulation number

870.1025

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary