Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2800](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2800) → MXC — Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) # MXC · Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) _Cardiovascular · 21 CFR 870.2800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC ## Overview - **Product Code:** MXC - **Device Name:** Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) - **Regulation:** [21 CFR 870.2800](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2800) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Implant:** yes ## Identification A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K230286](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K230286.md) | Assert-IQ™ Insertable Cardiac Monitor | ABBOTT MEDICAL | May 17, 2023 | SESE | | [K212206](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K212206.md) | Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | Aug 13, 2021 | SESE | | [K202876](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K202876.md) | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | Dec 1, 2020 | SESE | | [K202888](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K202888.md) | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | Nov 23, 2020 | SESE | | [K193310](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K193310.md) | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | Abbott (St. Jude Medical) | Mar 17, 2020 | SESE | | [K192593](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K192593.md) | Confirm Rx Insertable Cardiac Monitor | Abbott | Oct 18, 2019 | SESE | | [K190295](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K190295.md) | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | Apr 10, 2019 | SESE | | [K182981](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K182981.md) | Confirm Rx Insertable Cardiac Monitor | Abbott | Mar 29, 2019 | SESE | | [K173232](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K173232.md) | myMerlin(TM) Mobile Application Model APP1001 | St Jude Medical | Nov 2, 2017 | SESE | | [K163407](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K163407.md) | Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. | Sep 29, 2017 | SESE | | [K133481](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K133481.md) | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) | St. Jude Medical, Inc. | May 28, 2014 | SESE | | [K122161](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K122161.md) | SJM CONFIRM | St Jude Medical | Nov 28, 2012 | SESE | | [K122090](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K122090.md) | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR | St. Jude Medical, Cardiac Rhythm Management Divisi | Nov 15, 2012 | SESE | | [K101968](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K101968.md) | SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A | St Jude Medical | Sep 15, 2010 | SESE | | [K091206](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K091206.md) | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL | Transoma Medical | May 18, 2009 | SESE | | [K083828](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K083828.md) | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT | Transoma | Feb 11, 2009 | SESE | | [K081365](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K081365.md) | SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR | St Jude Medical | Aug 15, 2008 | SESE | | [K073147](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K073147.md) | SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 | Transoma Medical | Dec 3, 2007 | SESE | | [K063035](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K063035.md) | SLEUTH IMPLANTABLE ECG MONITORING SYSTEM | Transnoma Medical, Inc. | Oct 1, 2007 | SESE | | [K011098](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC/K011098.md) | REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR | Medtronic Vascular | May 4, 2001 | SESE | ## Top Applicants - Abbott (St. Jude Medical) — 5 clearances - Medtronic Vascular — 4 clearances - St Jude Medical — 4 clearances - Abbott — 2 clearances - St. Jude Medical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MXC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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