BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P860057 · Supplement: S220 · Decision Apr 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis
    PMA Number
    P860057
    Supplement Number
    S220
    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
    April 10, 2025
    Date Received
    October 31, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    modifications to the Instructions for Use to reflect the 8-year findings of the Post-Approval Study (PAS) Report submitted for the long term follow-up of the PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis prospective cohort study

    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