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510(k) Data Aggregation

    K Number
    K053656
    Device Name
    TYRX ANTIMICROBIAL MESH
    Manufacturer
    TYRX PHARMA INC
    Date Cleared
    2006-07-14

    (196 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TYRX PHARMA INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PivitAB™ is intended for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. Examples of applications where PivitAB™ may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
    Device Description
    PivitAB™ is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PivitAB™ is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a biorsonable polyarylate coating on the mesh containing the antimicrobial agents, rifampir and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the nesh in order to facilitate interoperative handling during placement and act a carrier for the imicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a ermanent mesh incorporated into the tissue.
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    K Number
    K052864
    Device Name
    TYRX SURGICAL MESH, MODEL SMPC-0501
    Manufacturer
    TYRX PHARMA INC
    Date Cleared
    2005-12-22

    (72 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TYRX PHARMA INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Is intended for the repair of hernias and other abdominal fascial deficioncies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. . Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
    Device Description
    TyRx Surgical Mesh is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. TyRx Surgical Mesh is constructed of a non-resorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh. The resorbable coating represents approximately 10% of the total weight of the device. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.
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