BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P050018 · Supplement: S004 · Decision Apr 23, 2008
    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
    ANGIOSCULPT SCORING BALLOON CATHETER
    PMA Number
    P050018
    Supplement Number
    S004
    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
    April 23, 2008
    Date Received
    March 12, 2008
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, INC., LOS ANGELES, CALIFORNIA AS AN ALTERNATE CONTRACT STERILIZATION FACILITY.

    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