BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P110042 · Supplement: S015 · Decision Sep 25, 2013
    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
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 25, 2013
    Date Received
    August 30, 2013
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    EXPAND RECEIVING AND INSPECTION ACTIVITIES FOR CERTAIN S-ICD® COMPONENTS AND ACCESSORIES TO BOSTON SCIENTIFIC¿S FACILITY LOCATED IN ST. PAUL, MINNESOTA.

    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)