BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P000009 · Supplement: S033 · Decision May 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    LUMOS DR-T AND LUMOS VR-T
    PMA Number
    P000009
    Supplement Number
    S033
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 12, 2009
    Date Received
    January 26, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION OF PRODUCT LABELING FOR DEVICES THAT UTILIZE HOME MONITORING. SPECIFICALLY, SUPPLEMENTS REQUESTED APPROVAL FOR THE REPLACEMENT OF EXISTINGPRECAUTIONS AND THE FOLLOWING MARKETING STATEMENTS:1) BIOTRONIC HOME MONITORING INFORMATION MAY BE USED AS A REPLACEMENT FORDEVICE INTERROGATION DURING IN-OFFICE FOLLOW-UP VISITS.2) A STRATEGY OF CARE USING BIOTRONIK HOME MONITORING WITH OFFICE VISITS WHEN NEEDED - HAS BEEN SHOWN TO EXTEND THE LIME BETWEEN ROUTINE, SCHEDULED IN-OFFICEFOLLOW-UPS OF BIOTRONIK IMPLANTABLE DEVICES IN MANY PATIENTS. HOME MONITORING DATA IS HELPFUL IN DETERMINING THE NEED FOR ADDITIONAL IN-OFFICE FOLLOW-UP.3) BIOTRONIK HOME MONITORING PATIENTS -WHO ARE FOLLOWED REMOTELY WITH OFFICEVISITS WHEN NEEDED - HAVE BEEN SHOWN TO HAVE SIMILAR NUMBERS OF STROKES, INVASIVE PROCEDURES AND DEATHS AS PATIENTS FOLLOWED WITH CONVENTIONAL IN-OFFICE FOLLOW-UPS.4) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF ARRHYTHMIAS.5) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF SILENT, ASYMPTOMATIC ARRHYTHMIAS.6) AUTOMATIC EARLY DETECTION OF ARRHYTHMIAS AND DEVICE SYSTEM ANOMALIES BYBIOTRONIK HOME MONITORING ALLOWS FOR EARLIER INTERVENTION THAN CONVENTIONAL IN-OFFICEFOLLOW-UPS.7) BIOTRONIK HOME MONITORING ALLOWS FOR IMPROVED ACCESS TO PATIENT DEVICE DATA COMPARED TO CONVENTIONAL IN-OFFICE FOLLOW-UPS SINCE DEVICE INTERROGATION IS AUTOMATICALLYSCHEDULED AT REGULAR INTERVALS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRM Defibrillator, Implantable, Dual-Chamber