BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Hemodynamic, Implantable

    PMA: P230040 · Supplement: S026 · Decision Feb 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    System, Hemodynamic, Implantable
    Trade Name
    Cordella Pulmonary Artery Sensor System (CorPASS)
    PMA Number
    P230040
    Supplement Number
    S026
    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
    February 13, 2026
    Date Received
    January 16, 2026
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    the removal of the current warning requiring continuous systemic heparin infusion and ACT 200 seconds during implantation and replaced it with a precaution recommending periodic flushing of the Delivery System side port with saline.

    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