BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Surgical, Absorbable, Polydioxanone

    PMA: N18331 · Supplement: S024 · Decision Dec 21, 1994
    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
    S024
    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
    December 21, 1994
    Date Received
    February 14, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    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