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

    Acid, Hyaluronic, Intraarticular

    PMA: P080020 · Supplement: S053 · Decision Jan 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    Gel-One
    PMA Number
    P080020
    Supplement Number
    S053
    Device Class
    FDA Class 3
    Product Code
    MOZ
    Generic Name
    Acid, hyaluronic, intraarticular
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 17, 2025
    Date Received
    December 19, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The sharing of the existing h-HAD (Gel-One intermediate) manufacturing equipment in Preparation Building-1 in the SKK Takahagi Plant currently used to manufacture Hyaluronic Acid extracted from chicken combs (existing h-Had) along with h-HAD made from Hyaluronic Acid extracted from bacterial fermentation (FHA-h-HAD). The existing validated cleaning method will be used for the shared equipment to assure the cleanliness and minimize risks of cross-contamination of FHA-h-HAD to the existing h-HAD production.

    Classifications

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

    Product Code Device Name
    MOZ Acid, Hyaluronic, Intraarticular