BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Temporary Non-Roller Type Right Heart Support Blood Pump

    PMA: P170011 · Supplement: S053 · Decision Apr 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Temporary Non-Roller Type Right Heart Support Blood Pump
    Trade Name
    Impella RP and Impella RP with SmartAssist
    PMA Number
    P170011
    Supplement Number
    S053
    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
    Approved
    Decision Code
    APPR
    Decision Date
    April 17, 2024
    Date Received
    March 18, 2024
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the Instructions for Use (IFU) to include warning statements and clinical recommendations related to risk of thrombus formation or deposition in the Impella RP and Impella RP with SmartAssist (Impella RPSA) catheters when indwelling venous lines or cannulas are present.

    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