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

    Temporary Non-Roller Type Left Heart Support Blood Pump

    PMA: P140003 · Supplement: S129 · 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 Left Heart Support Blood Pump
    Trade Name
    Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD
    PMA Number
    P140003
    Supplement Number
    S129
    Device Class
    FDA Class 3
    Product Code
    OZD
    Generic Name
    Temporary non-roller type left heart support blood pump
    Medical Specialty
    Unknown
    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
    OZD Temporary Non-Roller Type Left Heart Support Blood Pump