BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Organ Care System (Ocs) Heart System

    PMA: P180051 · Supplement: S009 · Decision Dec 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Organ Care System (Ocs) Heart System
    Trade Name
    Organ Care System™ (OCS™) Heart
    PMA Number
    P180051
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    QIK
    Generic Name
    Organ care system (OCS) heart system
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 16, 2025
    Date Received
    November 25, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change in the pressure test condition in the inline leak test performed during assembly.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QIK Organ Care System (Ocs) Heart System