BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P970032 · Supplement: S001 · Decision Aug 26, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SALEST SYSTEM
    PMA Number
    P970032
    Supplement Number
    S001
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 26, 1999
    Date Received
    July 9, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a contract packaging site located at Biotecnica Continental SA DE CV, Libramiento Oriente 124-C, Tijuana, BC 22490, Mexico.