BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P960007 · Supplement: S002 · Decision May 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    DERMAGRAFT-TC(TM)
    PMA Number
    P960007
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MGR
    Generic Name
    Dressing, wound and burn, interactive
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 29, 1998
    Date Received
    May 5, 1997
    Supplement Type
    Real-Time Process
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a post approval study assessing the incidence of burn wound infection in in patients who require a temporary wound covering, Dermagraft-TC, for surgically excised full-thickness and deep-partial thickness thermal burn wounds in patients who require sucha covering prior to autograft placement.

    Classifications

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

    Product Code Device Name
    MGR Dressing, Wound And Burn, Interactive