BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Temporary Non-Roller Type Left Heart Support Blood Pump

    PMA: P140003 · Supplement: S066 · Decision Jan 22, 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, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist System, and
    PMA Number
    P140003
    Supplement Number
    S066
    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
    January 22, 2020
    Date Received
    December 23, 2019
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for adding a caution to the Impella Instructions for Use label regarding continuing Impella therapy in cardiogenic shock patients where Extra-corporeal Membrane Oxygenation (ECMO) is to be initiated.

    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