BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P220032 · Decision Aug 8, 2023
    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
    POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
    PMA Number
    P220032
    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
    August 8, 2023
    Date Received
    December 20, 2022
    Expedited Review
    N
    Docket Number
    23M-3943

    Advisory Committee Statement

    Approval for the Boston Scientific Cardiac Cryoablation System using the POLARx Cryoablation Balloon Catheters. The device is indicated for the treatment of patients with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation (PAF). In addition it is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation. The SMARTFREEZE Cryo-Console is intended to be used with POLARx cryoablation balloon catheters only.

    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