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

    Permanent Defibrillator Electrodes

    PMA: P960030 · Supplement: S036 · Decision May 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    ISOFLEX (ISOFLEX S, ISOFLEX P, ISOFLEX OPTIM) AND PASSIVE PLUS FAMILY OF LEADS
    PMA Number
    P960030
    Supplement Number
    S036
    Device Class
    FDA Class 3
    Product Code
    NVY
    Generic Name
    Permanent defibrillator electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 3, 2012
    Date Received
    April 3, 2012
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.

    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