BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Contrast Media, Ultrasound

    PMA: P900059 · Supplement: S003 · Decision Aug 28, 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
    S003
    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
    August 28, 1995
    Date Received
    June 5, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR RELEASE OF FINAL PRODUCT BASED ON RESULTS FROM KINETIC QUANTITATIVE CHROMOGENIC LAL BATERIAL ENDOTOXIN TEST AND REPLACEMENT OF TAII COULTER COUNTER WITH MULTISIZER IIE COULTER COUNTER FOR PARTICLE SIZE MEASUREMENT

    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