BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P950022 · Supplement: S017 · Decision Jul 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ST.JUDE MEDICAL RIATA DEFIBRILLATION LEADS
    PMA Number
    P950022
    Supplement Number
    S017
    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
    July 1, 2003
    Date Received
    June 9, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A FLUOROSCOPIC MARKER IN THE HELIX TIP AND THE ADDITION OF NEW LEAD LENGTHS AND MINOR MODIFICATIONS TO THE SUTURE SLEEVE. THE LEADS ARE INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE ATRIUM OR THE VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.

    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)