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

    Catheter, Coronary, Atherectomy

    PMA: P900056 · Supplement: S045 · Decision Jun 6, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ROTAGLIDE(TM) LUBRICANT
    PMA Number
    P900056
    Supplement Number
    S045
    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
    June 6, 2000
    Date Received
    May 18, 2000
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES IN THE MANUFACTURING PROCESS, REMOVING ONE OF THE STEPS FROM THE RELEASE CRITERIA FOR ROTAGLIDE(TM) LUBRICANT, TO MOVE THE PACKAGING INSPECTION AND REVIEW OF THE CERTIFICATE OF ANALYSIS FROM BOSTON SCIENTIFIC CORP. NORTHWEST TO BOSTON SCIENTIFIC CORP'S MARINA BAY DISTRIBUTION CENTER IN QUINCY, MASSECHUSETTS.

    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