BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P000007 · Supplement: S001 · Decision Feb 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    PRIMA PLUS STENTLESS BIOPROSTHESIS
    PMA Number
    P000007
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    DYE
    Generic Name
    replacement Heart-valve
    Regulation Number
    870.3925
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 12, 2002
    Date Received
    April 27, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL TO ADDRESS THE ISSUE OF LONG-TERM CLINICAL EFFECTIVENESS OF THE EDWARDS XENOLOGIX ANTICALCIFICATION TREATMENT AS STIPULATED IN THE FEBRUARY 27, 2001 APPROVAL ORDER.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DYE Replacement Heart-Valve