BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P130026 · Decision Oct 24, 2014
    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
    TACTICATH QUARTZ SET
    PMA Number
    P130026
    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
    October 24, 2014
    Date Received
    November 29, 2013
    Expedited Review
    N
    Docket Number
    14M-1736

    Advisory Committee Statement

    APPROVAL FOR THE TACTICATH QUARTZ CATHETER AND TACTISYSQUARTZ® EQUIPMENT. THIS DEVICE IS INDICATED FOR USE IN CARDIACELECTROPHYSIOLOGICAL MAPPING AND FOR THE TREATMENT OF DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED IN CONJUNCTION WITH A COMPATIBLE RADIOFREQUENCY GENERATOR AND THREE-DIMENSIONAL 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