BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Mitral Valve Repair Devices

    PMA: P220003 · Supplement: S025 · Decision Sep 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Mitral Valve Repair Devices
    Trade Name
    PASCAL Precision Transcatheter Valve Repair System
    PMA Number
    P220003
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    NKM
    Generic Name
    Mitral valve repair devices
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 9, 2025
    Date Received
    August 15, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to reduce the receiving inspection levels for a component of the PASCAL Ace implant from 100% inspection to Lot Tolerance Percent Defective (LTPD)-based sampling

    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