BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Hemodynamic, Implantable

    PMA: P100045 · Supplement: S087 · Decision Nov 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    System, Hemodynamic, Implantable
    Trade Name
    CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000))
    PMA Number
    P100045
    Supplement Number
    S087
    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
    November 10, 2025
    Date Received
    August 29, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a software maintenance release (SMR 1.1) containing software modifications to the CardioMEMS HF System.

    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