BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P040036 · Supplement: S098 · Decision May 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    THERMOCOOL SMARTTOUCH SF Catheter
    PMA Number
    P040036
    Supplement Number
    S098
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 24, 2024
    Date Received
    April 26, 2024
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for changes to the Instructions for Use for the THERMOCOOL SMARTTOUCH Catheter and THERMOCOOL SMARTTOUCH SF Catheter to include the updated clinical data results from the final clinical study report for the Zero/Low Fluoroscopy Workflow

    Classifications

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

    Product Code Device Name
    LPB Cardiac Ablation Percutaneous Catheter