BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Surgical, Absorbable, Polydioxanone

    PMA: N18331 · Supplement: S027 · Decision May 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86

    Basic Information

    Device Name
    Suture, Surgical, Absorbable, Polydioxanone
    Trade Name
    PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
    PMA Number
    N18331
    Supplement Number
    S027
    Device Class
    FDA Class 2
    Product Code
    NEW
    Generic Name
    Suture, surgical, absorbable, polydioxanone
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 12, 1997
    Date Received
    September 23, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF PDS II (POLYDIOXANONE) SUTURE AS A COMPONENT OF THE ETHICON ENDOSUTURE SYSTEM AND FOR THE ADDITION OF ETHICON LTD., SCOTLAND, (ETHICON, LTD., P.O. BOX 408, BANKHEAD AVE., EDINBURGH, SCOTLAND AND ETHICON, LTD., KIRKTON CAMPUS, LIVINGSTON, WEST LOTHIAN, SCOTLAND) AS A MANUFACTURER OF PDS II SUTURE USED IN THE ETHICON ENDOSUTURE SYSTEM AND FOR THE ASSEMBLY OF THE SYSTEM COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ETHICON ENDOSUTURE SYSTEM AND IS INDICATED FOR USE IN ALLTYPES OF SOFT TISSUE APPROXIMATION, INCLUDING USE IN PEDIATRIC CARDIOVASCULAR TISSUE WHERE GROWTH IS EXPECTED TO OCCUR AND OPHTHALMIC SURGERY. PDS II SUTURE IS NOT INDICATED IN ADULT CARDIOVASCULAR TISSUE, MICROSURGERY AND NEURAL TISSUE. THESE SUTURES ARE PARTICULARLY USEFUL WHERE THE COMBINATION OF AN ABSORBABLE SUTURE AND EXTENDED WOUND SUPPORT (UP TO SIX WEEKS) IS DESIRABLE.

    Classifications

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

    Product Code Device Name
    NEW Suture, Surgical, Absorbable, Polydioxanone