BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Organ Care System (Ocs) Heart System

    PMA: P180051 · Supplement: S001 · Decision Apr 27, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Organ Care System (Ocs) Heart System
    Trade Name
    OCS Heart System
    PMA Number
    P180051
    Supplement Number
    S001
    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
    April 27, 2022
    Date Received
    November 8, 2021
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    22M-0715

    Advisory Committee Statement

    Approval for the Organ Care System (OCS) Heart System for expanding the indication to include donation-after-circulatory-death (DCD) donor hearts. The device is indicated for the preservation of donation-after-brain-death (DBD) hearts initially deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time). The OCS Heart System is also indicated for the ex vivo reanimation, functional monitoring, and beating-heart preservation of DCD hearts.

    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