BEUDAMED
    FDA PMA FDA Unclassified Approved 🇺🇸 United States

    Dressing, Wound, Drug

    PMA: P870069 · Supplement: S003 · Decision Feb 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    402
    Registration Numbers
    403

    Basic Information

    Device Name
    Dressing, Wound, Drug
    Trade Name
    BIOBRANE (R) II BLUE LABEL PRODUCT
    PMA Number
    P870069
    Supplement Number
    S003
    Device Class
    FDA Unclassified
    Product Code
    FRO
    Generic Name
    Dressing, wound, drug
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 22, 1991
    Date Received
    December 3, 1990
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    FRO Dressing, Wound, Drug