BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P110016 · Supplement: S006 · Decision Apr 18, 2013
    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
    BI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETERS
    PMA Number
    P110016
    Supplement Number
    S006
    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
    April 18, 2013
    Date Received
    January 24, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APROVAL FOR A MODIFIED CATHETER USING A TIP ELECTRODE WITH 12 IRRIGATION HOLES FROM THE CURRENTLY APPROVED SAFIRE BLU DUO BI-DIRECTIONAL ABLATION CATHETER WITH THE SHAFT AND HANDLE OF THE CURRENTLY APPROVED THERAPY COOL PATH BI-DIRECTIONAL ABLATION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERAPY COOL PATH DUO BI-DIRECTIONAL CATHETER AND IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND 1500T9 CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.

    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