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

    Catheter, Coronary, Atherectomy

    PMA: P900056 · Supplement: S195 · Decision Nov 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System
    PMA Number
    P900056
    Supplement Number
    S195
    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
    November 26, 2021
    Date Received
    October 28, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System and the Alair Bronchial Thermoplasty System is approved for the addition of automated ultrasonic cleaning equipment with forced air dryer at the supplier for components used in the Rotalink and ROTAPRO Advancers and Alair Catheter.

    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