BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990064 · Supplement: S004 · Decision Jun 7, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC MOSAIC PORCINE BIOPROSTHESES MODEL 305 (AORTIC) AND MODEL 310 (MITRAL)
    PMA Number
    P990064
    Supplement Number
    S004
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 7, 2001
    Date Received
    August 29, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE MEDTRONIC MOSAIC PORCINE BIOPROSTHESES, MODEL 305 (AORTIC) AND MODEL 310 (MITRAL).