BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P130005 · Decision Oct 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
    PMA Number
    P130005
    Device Class
    FDA Class 3
    Product Code
    MCX
    Generic Name
    CATHETER, CORONARY, ATHERECTOMY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 21, 2013
    Date Received
    March 15, 2013
    Expedited Review
    N
    Docket Number
    13M-1363

    Advisory Committee Statement

    APPROVAL FOR THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS). THE DEVICE IS INDICATED TO FACILITATE STENT DELIVERY IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD) WHO ARE ACCEPTABLE CANDIDATES FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OR STENTING DUE TO DE NOVO, SEVERELY CALCIFIED CORONARY ARTERY LESIONS.

    Classifications

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

    Product Code Device Name
    MCX Catheter, Coronary, Atherectomy