BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P900056 · Supplement: S068 · Decision Feb 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES GOLD PLATING PROCESS/FLOPPY GOLD
    PMA Number
    P900056
    Supplement Number
    S068
    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 21, 2002
    Date Received
    February 5, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORPORATION, MIAMI TECHNOLOGY CENTER, MIAMI, FLORIDA. THE FLOPPY GOLD GUIDE WIRE GOLD PLATING PROCESS WILL BE PERFORMED AT THIS FACILITY.

    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