Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
FDA product code MXC · 22 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.2800
- Review panel
- CV
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1998-01-16 – 2023-05-17
MXC
2023-05-17
MXC
2021-08-13
Jot Dx Insertable Cardiac Monitor
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MXC
2020-12-01
Confirm Rx Insertable Cardiac Monitor
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MXC
2020-11-23
Confirm Rx Insertable Cardiac Monitor
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MXC
2020-03-17
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
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MXC
2019-10-18
Confirm Rx Insertable Cardiac Monitor
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MXC
2019-04-10
Confirm Rx Insertable Cardiac Monitor
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MXC
2019-03-29
Confirm Rx Insertable Cardiac Monitor
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MXC
2017-11-02
myMerlin(TM) Mobile Application Model APP1001
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MXC
2017-09-29
Confirm Rx Insertable Cardiac Monitor (ICM) System
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MXC
2012-11-28
SJM CONFIRM
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MXC
2012-11-15
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
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MXC
2010-09-15
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
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MXC
2009-05-18
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
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MXC
2009-02-11
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT
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MXC
2008-08-15
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
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MXC
2007-12-03
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
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MXC
2007-10-01
SLEUTH IMPLANTABLE ECG MONITORING SYSTEM
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MXC
2001-05-04
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
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MXC
2001-02-14
REVEAL PLUS INSERTABLE LOOP RECORDER
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MXC
2000-01-21
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
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MXC
1998-01-16
REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM
View details →No matching devices.
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