BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mitral Valve Repair Devices

    PMA: P220003 · Supplement: S007 · Decision Jul 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Mitral Valve Repair Devices
    Trade Name
    PASCAL Precision Transcatheter Valve Repair System
    PMA Number
    P220003
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    NKM
    Generic Name
    Mitral valve repair devices
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 6, 2023
    Date Received
    March 16, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following manufacturing site to conduct ethylene oxide sterilization of the PASCAL Precision Transcatheter Valve Repair System (Models 20000GS, 20000IS, and 20000ISM): Sterigenics, Belgium located at Zoning Industriel de Petit-Rechain Avenue Andre Ernst 21 Verviers Liege, B-4800 BE.

    Classifications

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

    Product Code Device Name
    NKM Mitral Valve Repair Devices