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

    Temporary Non-Roller Type Right Heart Support Blood Pump

    PMA: P170011 · Supplement: S022 · Decision Mar 30, 2020
    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
    PMA Number
    P170011
    Supplement Number
    S022
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 30, 2020
    Date Received
    March 9, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Upgrade the laser welding workstation and associated Computer Numeric Control (CNC) program for the manufacture of the Pump Housing Assembly of the Impella RP catheter.

    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