BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P950037 · Supplement: S034 · Decision Mar 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60
    PMA Number
    P950037
    Supplement Number
    S034
    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
    Decision Code
    APPR
    Decision Date
    March 8, 2004
    Date Received
    July 14, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITION OF A DRUG COLLAR TO THE PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELOX SR AND IS INDICATED AS FOLLOWING: BOTRONIK'S SELOX SR TRANSVENOUS, STEROID-ELUTING, ACTIVE FIXATION ENDOCARDIAL LEADS ARE INDICATED FOR PERMANENT PACING AND SENSING. ACTIVE FIXATION PACING LEADS WITH A BIPOLAR (BP) IS-1 CONNECTOR CONFIGURATION ARE DESIGNED FOR USE IN CONJUNCTION WITH IMPLANTABLE PULSE GENERATORS WITH IS-1 HEADERS. THE LEADS MAY BE USED WITH SINGLE OR DUAL CHAMBER PACING SYSTEMS. THE SELOX SR LEAD MODELS ARE INTENDED FOR PLACEMENT IN EITHER THE RIGHT ATRIUM OR RIGHT VENTRICLE.

    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