BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P130005 · Supplement: S002 · Decision Feb 12, 2015
    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 (OAS)
    PMA Number
    P130005
    Supplement Number
    S002
    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
    February 12, 2015
    Date Received
    August 11, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE DESIGN OF THE ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP MODEL SIP-3000) INCLUDING THE ADDITION OF A SECONDARY MOTOR FEEDBACK PRINTED CIRCUIT BOARD, THE ADDITION OF A SHROUD OVER THE AC POWER CORD CONNECTION, THE ADDITION OF A 100% INSPECTION OF POWER JACK RETENTION, AND THE SELECTION OF AN ALTERNATE VENDOR FOR THE TIMER COMPONENT.

    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