BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Contrast Media, Ultrasound

    PMA: P900059 · Supplement: S004 · Decision Jun 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Contrast Media, Ultrasound
    Trade Name
    ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED
    PMA Number
    P900059
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    MJS
    Generic Name
    Contrast media, ultrasound
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 17, 1997
    Date Received
    September 3, 1996
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    97M-0392

    Advisory Committee Statement

    APPROVAL FOR ALBUNEX(R). THE DEVICE IS INDICATED FOR USE WITH TRANSVAGINAL ULTRASOUND TO ASSESS FALLOPIAN TUBE PATENCY.

    Classifications

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

    Product Code Device Name
    MJS Contrast Media, Ultrasound