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510(k) Data Aggregation

    K Number
    K110420
    Device Name
    OPHIRA MINI SLING SYSTEM
    Manufacturer
    PROMEDON S.A.
    Date Cleared
    2012-05-08

    (449 days)

    Product Code
    PAH, OPH, OTN
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEDON S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ophira™ Mini Sling System is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
    Device Description
    Ophira™ Mini Sling System consists of a sterile polypropylene sling and a sterile retractable insertion guide for sling placement. The sling is composed of monofilament polypropylene mesh between two polypropylene fixation arms; the fixation arms have multiple fixation points along the arms, which is the basis of the autofixing system, i.e., the two fixation arms are self anchored to the internus transobturator muscle and, therefore, the sling needs no sutures. An easily identifiable mark in the center of the mesh sling helps to achieve a symmetrically centered location for the proper placement of the sling. The sling has a suture inserted onto each fixation arm to provide the ability to adjust tension, if necessary, during the procedure for optimum suburethral support. These sutures are removed once the implantation procedure is completed.
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