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510(k) Data Aggregation
K Number
K053656Device Name
TYRX ANTIMICROBIAL MESH
Manufacturer
TYRX PHARMA INC
Date Cleared
2006-07-14
(196 days)
Product Code
FTL
Regulation Number
878.3300Why 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
K052864Device Name
TYRX SURGICAL MESH, MODEL SMPC-0501
Manufacturer
TYRX PHARMA INC
Date Cleared
2005-12-22
(72 days)
Product Code
FTL
Regulation Number
878.3300Why 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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