BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Hemodynamic, Implantable

    PMA: P230040 · Supplement: S015 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    System, Hemodynamic, Implantable
    Trade Name
    CorPASS System
    PMA Number
    P230040
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    MOM
    Generic Name
    System, hemodynamic, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 19, 2025
    Date Received
    May 2, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for to modifications in the implanter’s labeling to remove the mandatory Sensor recalibrations every 3 years.

    Classifications

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

    Product Code Device Name
    MOM System, Hemodynamic, Implantable