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

    PMA: P990064 · Supplement: S002 · Decision Aug 29, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MOSAIC PORCINE BIOPROSTHESIS
    PMA Number
    P990064
    Supplement Number
    S002
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 29, 2000
    Date Received
    August 1, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE VENDOR OF THE POLYESTER YARN USED IN THE MANUFACTURE OF THE MOSAIC PORCINE BIOPROSTHESIS. ALSO, INCLUSION OF THE PMA PRODUCT IN THE "MASTER SUBMISSION" SUBMITTED APRIL 3, 1998 TO P970031/S006 FREESTYLE AORTIC BIOPROSTHESIS. THE INFORMATION CONTAINED IN THE "MASTER SUBMISSION" IS DIRECTLY APPLICABLE TO THE POLYESTER YARN VENDOR CHANGE.