BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P040024 · Supplement: S055 · Decision Apr 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RESTYLANE INJECTABLE GEL
    PMA Number
    P040024
    Supplement Number
    S055
    Device Class
    FDA Class 3
    Product Code
    LMH
    Generic Name
    Implant, dermal, for aesthetic use
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 23, 2012
    Date Received
    November 4, 2011
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGE TO LABEL CHECK CRITERIA;2) EXTENSION OF COMPRESSED AIR DISTRIBUTION IN BUILDING 9 (PHASE 2); 3) SEALING OF VESSELS AFTER CLEAN OUT OF PLACE (COP) USING STERIKING POUCH; 4) CHANGED SAMPLING PROCEDURE FOR BIOBURDEN AND BACTERIAL ENDOTOXINS TESTS; 5) NEW SILICONIZATION AND LUER LOCK ADAPTOR ASSEMBLY PROCESSES 1ML GLASS SYRINGE AT BD; 6) TIGHTENING OF ANALYTICAL ACCEPTANCE LIMITS FOR HA CONTENT AND GEL CONTENT. CHANGEINVOLVES MODIFICATION OF ACCEPTANCE CRITERIA FOR INCOMING RAW MATERIAL, FOR A CRITICAL COMPONENT;7) TIGHTENING LIMITS FOR LIDOCAINE IN PROCESS CONTROL AND CHANGING FROM A CALCULATED TO AFIXED AMOUNT OF ADDED WATER FOR INJECTION (WFI); AND8) INSTALLATION OF NEW DIFFERENTIAL PRESSURE SENSORS.

    Classifications

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

    Product Code Device Name
    LMH Implant, Dermal, For Aesthetic Use