BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Material, Dressing, Surgical, Polylactic Acid

    PMA: P840062 · Supplement: S004 · Decision Jun 24, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Material, Dressing, Surgical, Polylactic Acid
    Trade Name
    COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS
    PMA Number
    P840062
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    LPG
    Generic Name
    MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
    Medical Specialty
    Unknown
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 24, 1993
    Date Received
    October 26, 1992
    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
    LPG Material, Dressing, Surgical, Polylactic Acid