BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P150005 · Supplement: S014 · Decision Dec 21, 2017
    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
    Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter
    PMA Number
    P150005
    Supplement Number
    S014
    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
    December 21, 2017
    Date Received
    February 22, 2017
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    17M-6970

    Advisory Committee Statement

    Approval for the Blazer and IntellaNav Open-Irrigated Ablation Catheters. The Blazer and IntellaNav Open-Irrigated Ablation Catheters, when used with a compatible Radiofrequency Controller and Irrigation Pump, are indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, radiofrequency ablation of sustain or recurrent Type 1 Atrial Flutter in patients age 18 or older, and 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