BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P920011 · Decision Nov 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    MAXIM PFS MODEL 033-301
    PMA Number
    P920011
    Device Class
    FDA Class 3
    Product Code
    DTB
    Generic Name
    permanent pacemaker Electrode
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 7, 1996
    Date Received
    March 17, 1992
    Expedited Review
    N
    Docket Number
    97M-0275

    Advisory Committee Statement

    APPROVAL FOR THE MAXIM(TM)(PFS) MODEL 033-301 PACING LEAD. THIS DEVICE IS INTENDED FOR CHRONIC PACING AND SENSING OF THE VENTRICLE WHEN USED WITH A COMNPATIBLE PULSE GENERATOR

    Classifications

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

    Product Code Device Name
    DTB Permanent Pacemaker Electrode