BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P950020 · Supplement: S072 · Decision Aug 18, 2016
    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
    WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE)
    PMA Number
    P950020
    Supplement Number
    S072
    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
    Approved
    Decision Code
    APPR
    Decision Date
    August 18, 2016
    Date Received
    January 29, 2016
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the atherotomes, adhesive, balloon catheter platform, device packaging and the sterilization process. The device, as modified, will be marketed under the trade name WOLVERINE Coronary Cutting Balloon (Monorail & Over-The-Wire) and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: Discrete (<15 mm in length), or tubular (10 mm to 20 mm in length); Reference Vessel Diameter (RVD) of 2.00 mm to 4.00 mm; Readily accessible to the device; Light to moderate tortuosity of proximal vessel segment; Non-angulated lesion segment (<45 Degrees); Smooth angiographic contour; Absence of angiographically visible thrombus and/or calcification.

    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