BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S114 · Decision Mar 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    SECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR
    PMA Number
    P980016
    Supplement Number
    S114
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 17, 2008
    Date Received
    October 31, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REMOVAL OF THE CONTRAINDICATION: ?PATIENTS WHOSE PRIMARY DISORDER IS BRADYARRHYTHMIA? AND FOR THE MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284DRG, MAXIMO II VR D284VRC, MODEL 9995 APPLICATION SOFTWARE VERSION 1.1 SYSTEMS, MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME: MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284VRC, MAXIMO II VR D284DRG MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. IN ADDITION, THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A PROLONGED QRS DURATION. ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP) AND POST MODE SWITCH OVERDRIVE PACING (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION.

    Classifications

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

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)