BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    PMA: P010068 · Decision Sep 27, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
    Trade Name
    NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER
    PMA Number
    P010068
    Device Class
    FDA Class 3
    Product Code
    OAD
    Generic Name
    catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 27, 2002
    Date Received
    December 31, 2001
    Expedited Review
    N
    Docket Number
    03M-0049

    Advisory Committee Statement

    APPROVAL FOR THE NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS, STOCKERT 70 GENERATOR AND ACCESSORIES. THE NAVISTAR DS AND CELSIUS DS CATHETERS AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING), AND FOR USE WITH THE STOCKERT 70 (MODEL S7001 WITH SOFTWARE VERSION 001/033) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE NAVISTAR DS CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO EP NAVIGATION SYSTEM.

    Classifications

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

    Product Code Device Name
    OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter