BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Organ Care System (Ocs) Heart System

    PMA: P180051 · Decision Sep 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Organ Care System (Ocs) Heart System
    Trade Name
    Organ Care System (OCS) Heart System
    PMA Number
    P180051
    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
    September 3, 2021
    Date Received
    December 26, 2018
    Expedited Review
    N
    Docket Number
    21M-0989

    Advisory Committee Statement

    Approval for the Organ Care System (OCS) Heart System. This device is indicated for the preservation of donor-after-brain-death (DBD) hearts 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).

    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