BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P910031 · Supplement: S015 · Decision May 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    ORACLE MEGASONICS FIVE-64 PTCA CATHETER
    PMA Number
    P910031
    Supplement Number
    S015
    Device Class
    FDA Class 2
    Product Code
    LOX
    Generic Name
    Catheters, transluminal coronary angioplasty, percutaneous
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 1, 1998
    Date Received
    March 28, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for Oracle MegaSonics Five-64(TM) PTCA Catheter. The device, as modified, will be marketed under the trade name Oracle MegaSonics Five-64(TM) PTCA Catheter and is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts for the purpose of improving myocardial perfusion. The catheter is further indicated for use following balloon dilatation as an adjunct to conventional angiographic procedures to provide: 1) an image of the vessel lumen and wall structures and 2) dimensional measurements from the image.

    Classifications

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

    Product Code Device Name
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous