BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Angioplasty, Laser, Coronary

    PMA: P910001 · Supplement: S005 · Decision Jul 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Device, Angioplasty, Laser, Coronary
    Trade Name
    SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
    PMA Number
    P910001
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    LPC
    Generic Name
    DEVICE, ANGIOPLASTY, LASER, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 31, 1995
    Date Received
    June 17, 1993
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR VITESSE-E (MODEL 117-005) & VITESSE-E II (MODEL 117-205) CATHETERS TO BE USED WITH THE CVX-300 EXCIMER LASER SYSTEM ON ECCENTRIC LESIONS MEETING ONE OR MORE OF YOUR APPROVED INDICATIONS FOR USE

    Classifications

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

    Product Code Device Name
    LPC Device, Angioplasty, Laser, Coronary