BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Hemodynamic, Implantable

    PMA: P100045 · Supplement: S050 · Decision Apr 6, 2021
    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
    S050
    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
    April 6, 2021
    Date Received
    March 9, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for manufacturing sites located at Midwest Sterilization Corporation, PO BOX 411, 1204 Lenco Avenue, Jackson, Missouri, USA, FEI: 1928237 for Ethylene Oxide Sterilization and Sterigenics US, LLC, 5725 W. Harold Gatty Drive, Salt Lake City, Utah, USA, FEI: 1721676 for Ethylene Oxide Sterilization.

    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