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

    System, Hemodynamic, Implantable

    PMA: P100045 · Supplement: S072 · Decision Jan 31, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    System, Hemodynamic, Implantable
    Trade Name
    CardioMEMS™ HF System
    PMA Number
    P100045
    Supplement Number
    S072
    Device Class
    FDA Class 3
    Product Code
    MOM
    Generic Name
    System, hemodynamic, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 31, 2024
    Date Received
    January 3, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    implementation of a new endotoxin test method (PyroGene assay)

    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