BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P900056 · Supplement: S060 · Decision Mar 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ROTABLATOR(R) ROTALINK ROTATIONAL ANGIOPLASTY SYSTEM AND ROTALINK(TM) PLUS WITH EXCHANGEABLE CATHETER
    PMA Number
    P900056
    Supplement Number
    S060
    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
    March 21, 2001
    Date Received
    February 6, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORK LTD. (BSCL), CORK, IRELAND AND A STERILIZATION FACILITY LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND.

    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