BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P080020 · Supplement: S018 · Decision Nov 25, 2015
    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
    S018
    Device Class
    FDA Class 3
    Product Code
    MOZ
    Generic Name
    Acid, hyaluronic, intraarticular
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 25, 2015
    Date Received
    August 31, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE MANUFACTURING AND STORING OF GEL-ONE® TO ALLOW FOR THE REFRIGERATION (5°C ± 3°C) OF IN-PROCESS PRODUCT (I.E. PRODUCT THAT HAS NOT YET BEEN PACKAGED AND LABELED) FOR A MAXIMUM OF 6 MONTHS FOLLOWING THE DATE OF TERMINAL STEAM STERILIZATION AND PRIOR TO INITIATION OF THE PRODUCT¿S PREVIOUSLY ESTABLISHED 12 MONTH SHELF LIFE WHEN STORED BELOW 25°C (WITHOUT FREEZING).

    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