BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Electrode Recording, Or Probe, Electrode Recording

    PMA: P990025 · Decision Jun 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86

    Basic Information

    Device Name
    Catheter, Electrode Recording, Or Probe, Electrode Recording
    Trade Name
    NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
    PMA Number
    P990025
    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
    June 15, 2000
    Date Received
    May 24, 1999
    Expedited Review
    N
    Docket Number
    00M-1388

    Advisory Committee Statement

    APPROVAL FOR THE NAVI-STAR(R) DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER. THE NAVI-STAR DIAGNOSTIC/ABLATION CATHETER, AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR CARDIAC MAPPING, AND WHEN USED WITH A COMPATIBLE RADIO FREQUENCY GENERATOR IN ADULTS AND CHILDREN 4 YEARS OF AGE AND OLDER FOR:* INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; INCLUDING PERSISTEND JUNCTIONAL RE-ENTRANT TACHYCARDIA (PJRT) ...

    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