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

    Temporary Non-Roller Type Left Heart Support Blood Pump

    PMA: P140003 · Supplement: S137 · Decision Apr 7, 2026
    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 5.5 with Smart Assist
    PMA Number
    P140003
    Supplement Number
    S137
    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
    April 7, 2026
    Date Received
    March 9, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the adoption of an additional sterilization site for the Impella 5.5 with SmartAssist S2 configuration into the site's current routine sterilization process established for other Impella products

    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