BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Oxygen, Aqueous

    PMA: P170027 · Decision Apr 2, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    System, Oxygen, Aqueous
    Trade Name
    TherOx Downstream System
    PMA Number
    P170027
    Device Class
    FDA Class 3
    Product Code
    MWG
    Generic Name
    System, oxygen, aqueous
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 2, 2019
    Date Received
    September 15, 2017
    Expedited Review
    N
    Docket Number
    19M-1582

    Advisory Committee Statement

    Approval for the TherOx Downstream System. This device is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patients left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.

    Classifications

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

    Product Code Device Name
    MWG System, Oxygen, Aqueous