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510(k) Data Aggregation
K Number
K051190Device Name
XENFORM SOFT TISSUE REPAIR MATRIX
Manufacturer
TEI BIOSCIENCES INC.
Date Cleared
2005-06-10
(31 days)
Product Code
PAJ, PAG, PAI
Regulation Number
878.3300Why 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
K002233Device Name
BVI SLING
Manufacturer
BIO-VASCULAR, INC.
Date Cleared
2000-10-13
(81 days)
Product Code
PAJ
Regulation Number
878.3300Why did this record match?
Product Code :
PAJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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