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

    Organ Care System (Ocs) Heart System

    PMA: P180051 · Supplement: S002 · Decision Feb 23, 2023
    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
    PMA Number
    P180051
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    QIK
    Generic Name
    Organ care system (OCS) heart system
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 23, 2023
    Date Received
    January 27, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Expand the clean room area at the existing manufacturing facility.

    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