BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Dermal Replacement

    PMA: P900033 · Supplement: S005 · Decision Apr 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Device, Dermal Replacement
    Trade Name
    INTEGRA DERMAL REGENERATION TEMPLATE
    PMA Number
    P900033
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MDD
    Generic Name
    Device, dermal replacement
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 30, 2001
    Date Received
    April 13, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE TRADE NAME. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME INTEGRA(R) DERMAL REGENERATION TEMPLATE AND IS INDICATED FOR THE POST EXCISIONAL TREATMENT OF LIFE-THREATENING FULL-THICKNESS OR DEEP PARTIAL-THICKNESS THERMAL INJURY WHERE SUFFICIENT AUTOGRAFT IS NOT AVAILABLE AT THE TIME OF EXCISION OR NOT DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT.

    Classifications

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

    Product Code Device Name
    MDD Device, Dermal Replacement