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510(k) Data Aggregation

    K Number
    K051190
    Device Name
    XENFORM SOFT TISSUE REPAIR MATRIX
    Manufacturer
    TEI BIOSCIENCES INC.
    Date Cleared
    2005-06-10

    (31 days)

    Product Code
    PAJ, PAG, PAI
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Xenform Soft Tissue Repair Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.
    Device Description
    Xenform Soft Tissue Repair Matrix is an acellular collagen material intended to be utilized for surgical procedures pertaining to the pelvic floor. Xenform Soft Tissue Repair Matrix is supplied sterile and provided in sheet form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs. Xenform Soft Tissue Repair Matrix is manufactured from bovine skin, one of the purest sources of collagen available. The source material is solely derived from cattle obtained in compliance with US and European requiatory requirements.
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    K Number
    K002233
    Device Name
    BVI SLING
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    2000-10-13

    (81 days)

    Product Code
    PAJ
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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