BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Electrode Recording, Or Probe, Electrode Recording

    PMA: P950005 · Supplement: S010 · Decision Oct 5, 2001
    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
    PMA Number
    P950005
    Supplement Number
    S010
    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
    October 5, 2001
    Date Received
    December 8, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXPANDING THE INDICATIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND IS INDICATED AS FOLLOWS: THE BIOSENSE WEBSTER CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORIES ARE INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH COMPATIBLE RADIOFREQUENCY GENERATORS IN ADULTS AND CHILDREN 4 YEARS OF AGE AND OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.

    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