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

    Catheter, Coronary, Atherectomy

    PMA: P900056 · Supplement: S156 · Decision Dec 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
    PMA Number
    P900056
    Supplement Number
    S156
    Device Class
    FDA Class 3
    Product Code
    MCX
    Generic Name
    CATHETER, CORONARY, ATHERECTOMY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 19, 2016
    Date Received
    December 2, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Transfer manufacturing for the RotaWire Extra Support Core Wires component from the approved vendor, Lake Region Medical Arvada, to Lake Region Medical Galway.

    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