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

    Temporary Non-Roller Type Right Heart Support Blood Pump

    PMA: P170011 · Supplement: S062 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Temporary Non-Roller Type Right Heart Support Blood Pump
    Trade Name
    Impella CP with SmartAssist; Impella 5.5 with SmartAssist
    PMA Number
    P170011
    Supplement Number
    S062
    Device Class
    FDA Class 3
    Product Code
    PYX
    Generic Name
    Temporary non-roller type right heart support blood pump
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 19, 2025
    Date Received
    November 19, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to change the clean room classification used for manufacturing at the Danvers, Massachusetts facility

    Classifications

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

    Product Code Device Name
    PYX Temporary Non-Roller Type Right Heart Support Blood Pump