BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Angioplasty, Laser, Coronary

    PMA: P910001 · Supplement: S032 · Decision Jul 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Device, Angioplasty, Laser, Coronary
    Trade Name
    CVX-3000 EXCIMER LASER CORONARY ATHRECTOMY (ELCA) SYSTEM
    PMA Number
    P910001
    Supplement Number
    S032
    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 29, 2009
    Date Received
    June 2, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE MATERIAL OF THE PROXIMAL COUPLER COMPONENT OF THE ELCA CATHETERS.

    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