BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P990064 · Supplement: S001 · Decision Aug 29, 2000
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    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
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    Basic Information

    Trade Name
    MOSAIC PORCINE BIOPROSTHESIS
    PMA Number
    P990064
    Supplement Number
    S001
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 29, 2000
    Date Received
    July 31, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE METHOD IN WHICH A RAW MATERIAL (AOA COMPOUND) IS SYNTHESIZED. THIS WILL RESULT IN THE RAW MATERIAL BEING RECEIVED IN A MORE PURIFIED FORM. IN ADDITION, THE QUALITY CONTROL TEST PERFORMED ON INCOMING INSPECTION WILL CHANGE FROM THE GRAVIMETRIC TEST METHOD TO THE NINHYDRIN TEST METHOD.