BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P920015 · Supplement: S196 · Decision Apr 25, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    SPRINT QUATTRO MRI SURESCAN LEAD MODEL 6946M
    PMA Number
    P920015
    Supplement Number
    S196
    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
    April 25, 2017
    Date Received
    January 25, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1.5 and 3T MR Conditional labeling for MRI SureScan Lead Model 6946M.

    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