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

    Material, Dressing, Surgical, Polylactic Acid

    PMA: P840062 · Supplement: S042 · Decision Oct 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Material, Dressing, Surgical, Polylactic Acid
    Trade Name
    COLLACOTE, COLLATAPE, COLLAPLUG ABSORABABLE COLLAGEN WOUND GRESSING FOR DENTAL SURGERY
    PMA Number
    P840062
    Supplement Number
    S042
    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
    October 16, 2014
    Date Received
    September 15, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    USE OF A NEW QUALITY CONTROL TEST METHOD.

    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