BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P850089 · Decision Jul 29, 1986
    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
    CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS
    PMA Number
    P850089
    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
    July 29, 1986
    Date Received
    December 17, 1985
    Expedited Review
    N
    Docket Number
    86M-0329

    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