BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Material, Dressing, Surgical, Polylactic Acid

    PMA: P840062 · Supplement: S008 · Decision May 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Material, Dressing, Surgical, Polylactic Acid
    Trade Name
    COLLACOTE, COLLAPLUG, COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
    PMA Number
    P840062
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    LPG
    Generic Name
    MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
    Medical Specialty
    Unknown
    Advisory Committee
    Dental
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 16, 2003
    Date Received
    April 16, 2003
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES AFFECTING MANUFACTURING PROCESSES INCLUDING: 1) QUALIFYING ADDITIONAL MANUFACTURING ROOM, 2) MODIFYING THE TEMPERATURE MONITORING METHOD, 3) ADDITION OF A DIFFERENT AGENT FOR CLEANSING THE MANUFACTURING AREA, AND 4) MODIFYING THE METHOD FOR DRYING THE WEIGHED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.

    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