BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Angioplasty, Laser, Coronary

    PMA: P870043 · Supplement: S014 · Decision Jan 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Device, Angioplasty, Laser, Coronary
    Trade Name
    SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER
    PMA Number
    P870043
    Supplement Number
    S014
    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
    January 29, 1992
    Date Received
    April 23, 1991
    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
    LPC Device, Angioplasty, Laser, Coronary