BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Angioplasty, Laser, Coronary

    PMA: P910001 · Supplement: S020 · Decision Oct 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Device, Angioplasty, Laser, Coronary
    Trade Name
    CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
    PMA Number
    P910001
    Supplement Number
    S020
    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
    October 10, 2001
    Date Received
    March 30, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL INDICATION, THE TREATMENT OF RESTENOSIS IN 316L STAINLESS STEEL STENTS, PRIOR TO THE ADMINISTRATION OF INTRAVASCULAR BRACHYTHERAPY, FOR THE CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM. THE INDICATION IS IN ADDITION TO THOSE LISTED IN THE FEBRUARY 19, 1993, APPROVAL LETTER.

    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