BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P950001 · Decision May 8, 1996
    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
    SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
    PMA Number
    P950001
    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
    May 8, 1996
    Date Received
    January 13, 1995
    Expedited Review
    N
    Docket Number
    96M-0371

    Advisory Committee Statement

    APPROVAL FOR THE SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 AND 4285

    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