BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P980023 · Supplement: S046 · Decision Feb 22, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    VIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS
    PMA Number
    P980023
    Supplement Number
    S046
    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
    February 22, 2012
    Date Received
    November 14, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING: 1) ADDITION OF TRADE NAMES VIGILA AND VOLTA FOR THE LINOX AND LINOX SMART DEFIBRILLATION LEADS; 2) CHANGE TO INDICATIONS FOR USE STATEMENT TO CLARIFY THAT THE VIGILA AND VOLTA LEADS MAYBE USED WITH ANY MANUFACTURERS' ICDS; AND 3) ACCESSORY KITS FOR USE WITH THE VIGILA AND VOLTA LEADS.

    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