BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Temporary Non-Roller Type Left Heart Support Blood Pump

    PMA: P140003 · Supplement: S124 · Decision Aug 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Temporary Non-Roller Type Left Heart Support Blood Pump
    Trade Name
    Impella CP with SmartAssist System
    PMA Number
    P140003
    Supplement Number
    S124
    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 8, 2025
    Date Received
    February 14, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a process update to 1) the manufacturing of the KR Pigtail at a second-tier supplier; and 2) sub-assembly processes performed at Abiomed.

    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