BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P900056 · Supplement: S018 · Decision Feb 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)
    PMA Number
    P900056
    Supplement Number
    S018
    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 13, 1997
    Date Received
    June 20, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ROTALINK(TM) EXCHANGEABLE CATHETER FOR THE ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM AND IS INDICATED FOR USE IN PATIENTS WITH CORONARY ARTERY DISEASE SHO ARE CANDIDATES FOR CORONARY ARTERY BYPASS GRAFT (CABG) SRUGERY AND WHO MEET ONE OF THE FOLLOWING CRITERIA:SINGLE VESSEL ATHEROSCLEROTIC CORONARY ARTERY DISEASE WITH A STENOSIS THAT CAN BE PASSED WITH A GUIDE WIRE; MULTIPLE VESSEL CORONARY ARTERY DISEASE THAT IN THE PHYSICIAN'S JUDGMENT DOES NOT POSE UNDO RISK TO THE PATIENT; CERTAIN PATIENTS WITH PREVIOUS PTCA, AND WHO HAVE A RESTENOSIS OF THE NATIVE VESSEL; OR NATIVE VESSEL ATHEROSCLEROTIC CORONARY ARTERY DISEASE THAT IS LESS THAN 25 MM IN LENGTH.

    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