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

    Temporary Non-Roller Type Right Heart Support Blood Pump

    PMA: P170011 · Supplement: S060 · Decision Sep 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 RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist
    PMA Number
    P170011
    Supplement Number
    S060
    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
    September 19, 2025
    Date Received
    August 22, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    addition of a third mounting screw for the Automated Impella Controller (AIC) purge assembly's purge disc retainer, implementation of a specification for the mounting screw torque during installation, and updates to the annual preventive maintenance procedure for the purge disc retainer

    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