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    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·April 27, 2022

    Merlin PCS 3650 programmer Model 3330 software

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·April 27, 2022

    Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·April 27, 2022

    Merlin 2 PCS MER3700 programmer Model MER3400 software

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·April 27, 2022

    Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·April 27, 2022

    Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 23, 2015

    Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·January 21, 2015

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Cardiac Rhythm Management Division·January 27, 2016

    Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·March 4, 2020

    Merlin 2 PCS MER37000 programmer Model MER3400 software

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·August 10, 2022

    Merlin PCS 3650 programmer Model 3330 software

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·August 10, 2022

    Merlin.net model MN5000 Software

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·August 10, 2022

    ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021