BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030036 · Decision Aug 3, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26

    Basic Information

    Device Name
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
    Trade Name
    MEDTRONIC SELECTSECURE LEAD MODEL 3830
    PMA Number
    P030036
    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
    Approved
    Decision Code
    APPR
    Decision Date
    August 3, 2005
    Date Received
    September 4, 2003
    Expedited Review
    N
    Docket Number
    05M-0380

    Advisory Committee Statement

    APPROVAL FOR THE SELECTSECURE LEAD MODEL 3830. THE MODEL 3830 LEAD HAS APPLICATIONS WHERE IMPLANTABLE ATRIAL OR VENTRICULAR, SINGLE-CHAMBER OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED. THE MODEL 3830 LEAD IS INTENDED FOR PACING AND SENSING IN THE ATRIUM OR VENTRICLE.

    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