BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Electrode Recording, Or Probe, Electrode Recording

    PMA: P950005 · Supplement: S016 · Decision Apr 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86

    Basic Information

    Device Name
    Catheter, Electrode Recording, Or Probe, Electrode Recording
    Trade Name
    NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS
    PMA Number
    P950005
    Supplement Number
    S016
    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 22, 2003
    Date Received
    June 7, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN THE STERILIZATION CYCLE PARAMETERS.

    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