BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Transmyocardial Revascularization

    PMA: P970029 · Supplement: S012 · Decision Sep 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    System, Laser, Transmyocardial Revascularization
    Trade Name
    SOLARGEN 2100S LASER
    PMA Number
    P970029
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    MNO
    Generic Name
    SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 11, 2008
    Date Received
    August 15, 2008
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE SOLARGEN 2100S LASER USER MANUAL.

    Classifications

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

    Product Code Device Name
    MNO System, Laser, Transmyocardial Revascularization