BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use In The Hands

    PMA: P040024 · Supplement: S099 · Decision May 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use In The Hands
    Trade Name
    Restylane Lyft with Lidocaine
    PMA Number
    P040024
    Supplement Number
    S099
    Device Class
    FDA Class 3
    Product Code
    PKY
    Generic Name
    Implant, dermal, for aesthetic use in the hands
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 18, 2018
    Date Received
    August 29, 2017
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    18M-1970

    Advisory Committee Statement

    Approval for the Restylane Lyft with Lidocaine for expanding the indications to include injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21

    Classifications

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

    Product Code Device Name
    PKY Implant, Dermal, For Aesthetic Use In The Hands