BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Electrode Recording, Or Probe, Electrode Recording

    PMA: P990025 · Supplement: S065 · Decision Sep 22, 2021
    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 and EZ STEER
    PMA Number
    P990025
    Supplement Number
    S065
    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
    September 22, 2021
    Date Received
    May 17, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updated labeling, including modified warnings and directions for use.

    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