BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030036 · Supplement: S040 · Decision Nov 2, 2012
    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
    Supplement Number
    S040
    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
    November 2, 2012
    Date Received
    February 6, 2012
    Supplement Type
    Normal 180 Day Track No User Fee
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR IMPROVEMENTS TO THE SELECTSECURE MODEL 3830 LEAD DRUG METHODS AND SPECIFICATIONS.

    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