BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P960030 · Supplement: S032 · Decision Jul 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS
    PMA Number
    P960030
    Supplement Number
    S032
    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
    July 25, 2011
    Date Received
    August 16, 2010
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERTIONS (MY) SDN. BHD. IN BAYAN LEPAS, MALAYSIA.

    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