BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P110042 · Decision Sep 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
    PMA Number
    P110042
    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
    September 28, 2012
    Date Received
    December 23, 2011
    Expedited Review
    Y
    Docket Number
    12M-1048

    Advisory Committee Statement

    APPROVAL FOR THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THIS DEVICE IS INDICATED TO PROVIDE DEFIBRILLATION THERAPY FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS INPATIENTS WHO DO NOT HAVE SYMPTOMATIC BRADYCARDIA, INCESSANT VENTRICULAR TACHYCARDIA, OR SPONTANEOUS, FREQUENTLY RECURRING VENTRICULAR TACHYCARDIA THAT IS RELIABLY TERMINATED WITH ANTITACHYCARDIA PACING.

    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)