BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P020012 · Supplement: S023 · Decision Apr 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    Bellafill Dermal Filler
    PMA Number
    P020012
    Supplement Number
    S023
    Device Class
    FDA Class 3
    Product Code
    LMH
    Generic Name
    Implant, dermal, for aesthetic use
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 11, 2018
    Date Received
    March 13, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Resurrection and utilization of subassembly batch record, SAN 8004, 8th Purified Collagen Cake, for formulation in SAN 8005, 3.5% Atelocollagen with 0.3% Lidocaine, 20cc Syringe, on an as needed basis only.

    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