BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Contrast Media, Ultrasound

    PMA: P900059 · Supplement: S001 · Decision Jul 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Contrast Media, Ultrasound
    Trade Name
    ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
    PMA Number
    P900059
    Supplement Number
    S001
    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
    July 31, 1995
    Date Received
    September 12, 1994
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 2 TRAINING VIDOES.FDA HAS RECEIVED A JOURNAL ADVERTISING INSERT, PRODUCT FOLDER, & 2 JOURNAL ARTICLES & FIND THAT THEY ARE CONSISTENT WITH APPROVED LABELING.EXPIRATION DATING 12 MONTHS REFRIGERATED AT 2 TO 8 DEGREES CELSIUS

    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