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

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    PMA: P950020 · Supplement: S081 · Decision Aug 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
    Trade Name
    Flextome Cutting Balloon Microsurgical Dilatation Device/Wolverine Coronary Cutting Balloon Monorail (MR) / Wolverine Co
    PMA Number
    P950020
    Supplement Number
    S081
    Device Class
    FDA Class 3
    Product Code
    NWX
    Generic Name
    Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 18, 2017
    Date Received
    July 20, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Alternate degreaser used in the cleaning process for the cutting blades (atherotomes).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring