BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Temporary Non-Roller Type Left Heart Support Blood Pump

    PMA: P140003 · Supplement: S072 · Decision Aug 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Temporary Non-Roller Type Left Heart Support Blood Pump
    Trade Name
    Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist
    PMA Number
    P140003
    Supplement Number
    S072
    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
    Approved
    Decision Code
    APPR
    Decision Date
    August 4, 2020
    Date Received
    March 30, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for: 1) a new design for the Impella 2.5, Impella CP, and Impella CP with SmartAssist pigtail subcomponent; 2) the addition of a second supplier for the new pigtail design; and 3) a change in material and supplier of the encapsulant on the optical sensor used on the Impella CP with SmartAssist and the Impella 5.5 with SmartAssist catheters.

    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