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

    Material, Dressing, Surgical, Polylactic Acid

    PMA: P840062 · Supplement: S097 · Decision May 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Material, Dressing, Surgical, Polylactic Acid
    Trade Name
    CollaCote® and CollaTape® Absorbable Collagen Wound Dressings for Dental Surgery
    PMA Number
    P840062
    Supplement Number
    S097
    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 27, 2026
    Date Received
    April 27, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    an extension of Dirty Hold Time (DHT) for equipment used in cutting collagen during the manufacture of absorbable collagen products, and the installation of a new Clean Compressed Air Point of Use utility in the alternative ISO 8 Cleanroom

    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