BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Balloon, Transcervical

    PMA: P970021 · Supplement: S012 · Decision Jan 3, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Catheter, Balloon, Transcervical
    Trade Name
    GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
    PMA Number
    P970021
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    MKN
    Generic Name
    Catheter, balloon, transcervical
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 3, 2005
    Date Received
    December 17, 2004
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE, OPERATING MANUAL AND CONTROLLER PULL-OUT CARD.

    Classifications

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

    Product Code Device Name
    MKN Catheter, Balloon, Transcervical