BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P950037 · Supplement: S024 · Decision Apr 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    SOLOX VDD PACING LEAD
    PMA Number
    P950037
    Supplement Number
    S024
    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
    April 23, 2003
    Date Received
    December 31, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE SOLOX VDD PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOLOX VDD PACING LEAD AND IS INDICATED AS FOLLOWS: THE SOLOX LEAD IS INDICATED FOR USE AS PART OF A SYSTEM ONLY. THE SYSTEM INCLUDES ANY OF BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS AND THE SOLOX VDD LEAD. THEREFORE, THE INDICATIONS FOR THE SOLOX VDD LEAD ARE IDENTICAL TO THE INDICATIONS FOR USE OF BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS. BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS ARE PRIMARILY INTENDED TO PROVIDE VDD PACING FOR PATIENTS WITH A HEALTHY SINUS NODE. THESE PULSE GENERATORS ARE SPECIFICALLY INDICATED FOR PATIENTS WHO NEED VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES ARE PRESENT. THIS INCLUDES THE PRESENCE OF COMPLETE A-V BLOCK WHEN: 1) ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT AND 2) PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED. ADDITIONAL INDICATIONS INCLUDE: NORMAL SINUS RHYTHM AND NORMAL A-V CONDUCTIONS IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING SUPPORT. NOTE: PATIENTS WITH KNOWN PAROXYSMAL ATRIAL FIBRILLATION/FLUTTER MAY REQUIRE FURTHER EVALUATION PRIOR TO IMPLANTATION. OTHER PACING MODES ARE INCORPORATE DIN THE PULSE GENERATOR (VDDR, VVI, VVIR, VOO, VOOR, VDT, VVT, AND VDI) IN ORDER TO PROVIDE CLINICAL FLEXIBILITY TO MANAGE CHANGES IN THE PATIENT'S CONDITION, FOR DIAGNOSTIC PURPOSES, OR IN THE EVENT THAT VDD PACING BECOMES INAPPROPRIATE.

    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