BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Electrode Recording, Or Probe, Electrode Recording

    PMA: P950005 · Supplement: S004 · Decision Apr 5, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86

    Basic Information

    Device Name
    Catheter, Electrode Recording, Or Probe, Electrode Recording
    Trade Name
    CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER WITH 5MM TIP ELECTRODE
    PMA Number
    P950005
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    DRF
    Generic Name
    CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 5, 1999
    Date Received
    February 22, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the 7 Fr and 8 Fr catheters incorporating a 5mm tip electrode. The device, as modified, will be marketed under the trade name Celsius(TM) Diagnostic/Ablation Deflectable Braided Tip Catheter (5mm Tip Electrode) and is indicated for interruption of accessory AV conduction pathways assocated with tachycardia, the treatment of AV nodal reentrant tachycardia (AVNRT), and creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia. In addition to these indications, the 7 Fr catheter is also indicated for persistent junctional reciprocating tachycardia, Mahaim fibers, and pediatric patients (age 4 years or older).

    Classifications

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

    Product Code Device Name
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording