BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S046 · Decision Jun 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWAR
    PMA Number
    P980016
    Supplement Number
    S046
    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
    June 14, 2005
    Date Received
    January 12, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND THE MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT ARE INDICATED FOR USE IN ICD PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE ENTRUST MODELS D153DRG, D153VRC AND D154 DRG ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. THE ENTRUST MODELS D153ATG AND D1534ATG ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. IN ADDITION, THE DEVICE IS INTENDED TO PROVIDE PACING, CARDIOVERSION, AND DEFIBRILLATION FOR TREATMENT OF PATIENTS WITH: 1) SYMPTOMATIC, DRUG-REFRACTORY ATRIAL FIBRILLATION AND/OR 2) LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS. ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP) AND POST MODE SWITCH OVERDRIVE (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND ONE OR MORE OF THE ABOVE ICD INDICATIONS. NOTES: A) USE OF THE DEVICE HAS NOT BEEN DEMONSTRATED TO DECREASE THE MORBIDITY RELATED TO ATRIAL TACHYARRHYTHMIAS. B) THE EFFECTIVENESS OF HIGH FREQUENCY BURST PACING (ATRIAL-50HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 17% , AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 16.85% IN THE VT/AT POPULATION STUDIED. C) THE EFFECTIVENESS OF HIGH FREQUENCY BURST PACING (ATRIAL-50HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 11.7% , AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 18.2% IN THE AF ONLY POPULATION STUDIED.

    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)