BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Balloon For Retinal Reattachment

    PMA: P820009 · Supplement: S003 · Decision Sep 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Catheter, Balloon For Retinal Reattachment
    Trade Name
    LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER
    PMA Number
    P820009
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    LOG
    Generic Name
    Catheter, balloon for retinal reattachment
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 18, 1986
    Date Received
    August 15, 1986
    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
    LOG Catheter, Balloon For Retinal Reattachment