BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Dermal Replacement

    PMA: P900033 · Supplement: S042 · Decision Jan 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Device, Dermal Replacement
    Trade Name
    INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO
    PMA Number
    P900033
    Supplement Number
    S042
    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
    January 7, 2016
    Date Received
    January 29, 2015
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    16M-0121

    Advisory Committee Statement

    APPROVAL FOR THE INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX (A.K.A. OMNIGRAFT) AND INTEGRA DERMAL REGENERATION TEMPLATE. INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX IS INDICATED FOR USE IN THE TREATMENT OF PARTIAL AND FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS THAT ARE GREATER THAN SIX WEEKS IN DURATION, WITH NO CAPSULE, TENDON OR BONE EXPOSED, WHEN USED IN CONJUNCTION WITH STANDARD DIABETIC ULCER CARE AND INTEGRA DERMAL REGENERATION TEMPLATE IS INDICATED FOR THE POSTEXCISIONAL TREATMENT OF LIFE-THREATENING FULL-THICKNESS OR DEEP PARTIAL-THICKNESS THERMAL INJURIES WHERE SUFFICIENT AUTOGRAFT IS NOT AVAILABLE AT THE TIME OF EXCISION OR NOT DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT; REPAIR OF SCAR CONTRACTURES WHEN OTHER THERAPIES HAVE FAILED OR WHEN DONOR SITES FOR REPAIR ARE NOT SUFFICIENT OR DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT; AND TREATMENT OF PARTIAL AND FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS THAT ARE GREATER THAN SIX WEEKS IN DURATION WITH NO CAPSULE, TENDON OR BONE EXPOSED, WHEN USED IN CONJUNCTION WITH STANDARD DIABETIC ULCER CARE.

    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