BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P150005 · Supplement: S074 · Decision Feb 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
    Trade Name
    INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System
    PMA Number
    P150005
    Supplement Number
    S074
    Device Class
    FDA Class 3
    Product Code
    OAE
    Generic Name
    Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 26, 2024
    Date Received
    February 3, 2023
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping SystemThe INTELLANAV STABLEPOINT Catheter, when used with a compatible Radiofrequency Controller and IrrigationPump, is indicated for:• Cardiac electrophysiological mapping• Delivering diagnostic pacing stimuli• RF ablation of sustained or recurrent typical atrial flutter in patients age 18 years or older• Treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    Classifications

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

    Product Code Device Name
    OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation