BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P050024 · Decision Aug 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
    Trade Name
    CRYOCOR CRYOABLATION SYSTEM
    PMA Number
    P050024
    Device Class
    FDA Class 3
    Product Code
    OAD
    Generic Name
    catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    August 1, 2007
    Date Received
    July 15, 2005
    Expedited Review
    N
    Docket Number
    07M-0303

    Advisory Committee Statement

    APPROVAL FOR THE CRYOCOR CRYOABLATION SYSTEM. THE DEVICE IS INDICATED FOR USE IN THE ABLATION OF ISTHMUS-DEPENDENT RIGHT ATRIAL FLUTTER IN PATIENTS 18 YEARS OF AGE OR OLDER.

    Classifications

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

    Product Code Device Name
    OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter