BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device. Laser Peripheral Angioplasty

    PMA: P860042 · Supplement: S023 · Decision Jan 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Device. Laser Peripheral Angioplasty
    Trade Name
    TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
    PMA Number
    P860042
    Supplement Number
    S023
    Device Class
    FDA Class 3
    Product Code
    LWX
    Generic Name
    Device. Laser peripheral angioplasty
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 18, 1990
    Date Received
    November 24, 1989
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LWX Device. Laser Peripheral Angioplasty