BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P950022 · Supplement: S079 · Decision Sep 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    DURATA LEADS
    PMA Number
    P950022
    Supplement Number
    S079
    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
    September 13, 2012
    Date Received
    November 7, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN CHANGES TO THE HELIX-SHAFT SUBASSEMBLY OF MARKET APPROVED TENDRIL MODELS 1882, 1888, 1988, 2088 AND DURATA MODELS 7120Q, 7121Q, 7122Q, 7120, 7121, 7122, 7130, AND 7131 LEADS FOR IMPROVED MANUFACTURABILITY AND COST.

    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