BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P050052 · Supplement: S018 · Decision Feb 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RADIESSE INJECTABLE IMPLANT
    PMA Number
    P050052
    Supplement Number
    S018
    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
    February 3, 2009
    Date Received
    December 9, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1. CHANGING THE FILL VOLUME FROM A MAXIMUM DELIVERABLE FILL VOLUME OF 1.3 CC TO A MAXIMUM DELIVERABLE FILL VOLUME OF 1.5 CC.2. CHANGING THE SYRINGE BARREL HANDLE FROM A MOLDED STRAIGHT HANDLE TO A MOLDED HANDLE WITH AN ERGONOMIC CURVED HANDLE.3. MODIFICATION TO THE INSTRUCTION FOR USE TO INCLUDE THE 1.5 CC FILL VOLUME IN THE DEVICEDESCRIPTION SECTION OF THE INSTRUCTIONS FOR USE.4. CREATION OF PACKAGE LABELING SPECIFIC TO THE 1.5 CC FILL VOLUME, IDENTICAL TO THE PACKAGE LABELING FOR THE 0.3 CC AND 1.3 CC FILL VOLUME PRODUCTS WITH THE EXCEPTION OF THE IDENTIFIED FILL VOLUME AND PART NUMBER.

    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