BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P950022 · Supplement: S042 · Decision Jan 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    RIATA ST OPTIM AND RIATA STS OPTIM
    PMA Number
    P950022
    Supplement Number
    S042
    Device Class
    FDA Class 3
    Product Code
    NVY
    Generic Name
    Permanent defibrillator electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 13, 2009
    Date Received
    September 5, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ST. JUDE MEDICAL SJ4 QUADRIPOLAR DEFIBRILLATION SYSTEMCONSISTING OF DEVICE MODELS ATLAS II+HF V366Q AND PROMOTE 3107-36Q; LEAD MODELS RIATA STOPTIM 7020Q, 7021Q, 7022Q, AND RIATA STS OPTIM 7120Q, 7121Q, 7122Q; AND PROGRAMMER MODELS SJM 3510 AND MERLIN 3650.

    Classifications

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

    Product Code Device Name
    NVY Permanent Defibrillator Electrodes