BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P970021 · Supplement: S004 · Decision Feb 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    THERMA CHOICE UTERINE BALLON THERAPY SYSTEM
    PMA Number
    P970021
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    MNB
    Generic Name
    Device, thermal ablation, endometrial
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 13, 2001
    Date Received
    August 7, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO TRANSFER THE THERMACHOICE CATHETER MANUFACTURING OPERATIONS TO A NEW MANUFACTURING FACILITY LOCATED AT ETHICON, INC., CHIHUAHUA, MEXICO.

    Classifications

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

    Product Code Device Name
    MNB Device, Thermal Ablation, Endometrial