BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Temporary Non-Roller Type Right Heart Support Blood Pump

    PMA: P170011 · Supplement: S035 · Decision Apr 19, 2022
    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 System, Impella RP with SmartAssist System
    PMA Number
    P170011
    Supplement Number
    S035
    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 19, 2022
    Date Received
    August 5, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for revising the Instructions for Use to allow the use of sodium bicarbonate (25 or 50 mEq/L) as an alternative to heparin (25 or 50 U/mL) in the purge fluid during clinical use of the Impella catheters in patients intolerant to heparin or in whom heparin is contraindicated.

    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