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

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    PMA: P960004 · Supplement: S116 · Decision Jun 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
    Trade Name
    ThinLine/FineLine Family of Endocardial Pacing Leads Models: 4456, 4457, 4469, 4470, 4471, 4479, 4480
    PMA Number
    P960004
    Supplement Number
    S116
    Device Class
    FDA Class 3
    Product Code
    NVN
    Generic Name
    Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 3, 2026
    Date Received
    May 5, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the addition of a new controlled environment area (CEA) at the Boston Scientific Dorado, Puerto Rico facility

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes