BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use In The Hands

    PMA: P050052 · Supplement: S049 · Decision Jun 4, 2015
    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
    RADIESSE INJECTABLE IMPLANT
    PMA Number
    P050052
    Supplement Number
    S049
    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
    June 4, 2015
    Date Received
    December 2, 2013
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    15M-2078

    Advisory Committee Statement

    APPROVAL FOR THE RADIESSE® INJECTABLE IMPLANT. THE DEVICE IS INDICATED FOR HAND AUGMENTATION TO CORRECT VOLUME LOSS IN THE DORSUM OF THE HANDS

    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