Device Dossier

GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL - Abdominal hernia surgical mesh, composite-polymer

Device Dossier for GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL - Abdominal hernia surgical mesh, composite-polymer (Abdominal hernia surgical mesh,…

Intended purpose

The GORE® SYNECOR Intraperitoneal Biomaterial device is intended for use as a non-absorbable reinforcing or bridging material with placement between parietal and visceral tissue.

Functional description

The Biomaterial is a composite mesh comprised of a non-absorbable macroporous knit constructed of monofilament polytetrafluoroethylene (PTFE) fibers. The visceral surface is a bioabsorbable synthetic nonporous film comprised of poly (glycolide:trimethylene carbonate) copolymer (PGA:TMC). The parietal surface is a bioabsorbable synthetic porous fibrous structure comprised of PGA:TMC copolymer. GORE® SYNECOR Intraperitoneal Biomaterial is designed for intraperitoneal placement.

TGA Public Summary