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510(k) Data Aggregation
K Number
K130428Device Name
COVAMESH
Manufacturer
Date Cleared
2013-10-25
(247 days)
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOMUP S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-resorbable three dimensional polyester mesh provides long-term reinforcement of soft tissues.
Device Description
COVAMESH™ is a surgical mesh used during open procedures (laparotomy) or during laparoscopic procedures. COVAMESHIM is made from polyethylene terephtalate (polyester) and a cross-linked resorbable collagen film of porcine origin. The hydrophilic collagen film physically separates the coated side of the mesh from adjacent tissue, viscera, and organs. A marking with a non-resorbable ink is at the centre of the mesh to help positioning the device. The surgical mesh is obtained by standardized, controlled manufacturing processes. COVAMESHI™ is further sterilized in double-blisters by gamma-imadiation. COVAMESH™ is designed to be non inflammatory and biocompatible to allow reinforcement of soft tissues. When wetted, the surgical mesh is rollable to be easily introduced in a trocar. COVAMESH™ is suturable in place. It is provided in round sheets of 12 cm diameter and 16cm diameter and in rectangular sheets of 15x10 cm, 20x15 cm, 25x20 cm, 30x20 cm, 36x30 cm.
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