BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Collagen For Non-Aesthetic Use

    PMA: P800022 · Supplement: S013 · Decision Nov 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Implant, Collagen For Non-Aesthetic Use
    Trade Name
    ZYDERM COLLAGEN IMPLANT (ZYDERM CI)
    PMA Number
    P800022
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    LMI
    Generic Name
    IMPLANT, COLLAGEN FOR NON-AESTHETIC USE
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 22, 1985
    Date Received
    August 26, 1985
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LMI Implant, Collagen For Non-Aesthetic Use