Search Results

The Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of diaphragmatic/hiatal hernias. The graft is supplied sterile and intended for one time use.

The Diaphragmatic Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at the time of implant. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate Permacol™ Surgical Implant (K120605), manufactured by Covidien. The Diaphragmatic Hernia Graft is substantially equivalent to its SIS predicates in that its technology is able to be incorporated into the body. The device is also substantially equivalent to its predicates in its intended use for reinforcement and repair of diaphragmatic/hiatal hernias. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.