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The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

The GORE® Tri-Lobe Balloon Catheter is a compliant, tri-lobed polyurethane balloon catheter. The lobed design of the balloon catheter is designed for inflation without complete blockage of aortic blood flow. The three polyurethane balloons are mounted on the leading end of a multi-lumen catheter shaft. Radiopaque markers indicate the balloon edges. Each of the three inflation lumens is in communication with one of the balloons. The inflation port is in communication with all of the inflation lumens and is affixed with a luer lock. The guidewire lumen allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the guidewire lumen is affixed with a flushing/guidewire port with a luer lock, used for flushing the guidewire lumen. A Tuohy-Borst valve is integrated into the trailing end of the guidewire lumen. The GORE® Tri-Lobe Balloon Catheter is available in two sizes. The smaller balloon can be inflated to diameters of 16 mm to 32 mm and the larger balloon can be inflated to diameters of 26 mm to 48 mm.

The GORE® PROPATEN® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering from occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

GORE® PROPATEN® Vascular Graft is intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access. The GORE® ACUSEAL Vascular Graft is a multi-layer vascular graft with a low bleed layer between the inner and outer layers of ePTFE (expanded polytetrafluoroethylene). The luminal surface of the inner graft component is coated with the CBAS® Heparin Surface.

GORE® ENFORM Biomaterial is indicated for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® ENFORM Biomaterial may be used include hernia repair as suture-line reinforcement, muscle flap reinforcement, and general tissue reconstructions.

As packaged, GORE® ENFORM Biomaterial is a porous, three-dimensional sheet comprised of a bioabsorbable PGA:TMC copolymer in a matrix (scaffold) structure that functions to reinforce soft tissue during the phases of wound healing by filling soft-tissue deficits. The bioabsorbable, porous scaffold structure of the ENFORM device elicits a physiological response which fills the deficit with native tissue and gradually absorbs the device. There are two configurations of the GORE® ENFORM Biomaterial. One configuration will possess an added PGA:TMC film layer on one side of the device to provide visceral protection in soft tissue reinforcement applications requiring intraperitoneal contact with the viscera. Both ENFORM configurations are available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The GORE® ENFORM Biomaterial is supplied sterile for single use only.

GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. It can be used for reinforcement of staple lines during hysterectomy, lung resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. It is also intended to be used for remforcement of suture lines and staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

The subject of this 510(k) pre-market notification is a modification to the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material Configured for Endoscopic Surgical Staplers (EBSG, also referred to as the predicate) to include altered bioabsorbable sheet geometries, tailored lattice stitching, and inner dimension geometry for both the cartridge and anvil devices. The cartridge and anvil devices were specifically designed to fit the geometry of the Intuitive SureForm 60™ mm staplers (K173721 cleared July 5, 2018) Black, Green and Blue cartridge reloads. GORE® SEAMGUARD® Reinforcement Bioabsorbable Staple Line Reinforcement Configured for Intuitive Surgical® Robotic Endoscopic Surgical Staplers (EBSG-R, also referred to as the modified device) possesses the same fundamental scientific technology as the predicate. No other physical modifications were made to the predicate device, and the implantable materials of the modified device and predicate are the same synthetic bioabsorbable poly (glycolide: trimethylene carbonate) copolymer (PGA:TMC).

GORE® SYNECOR PREPERITONEAL Biomaterial is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material.

GORE® SYNECOR Preperitoneal Biomaterial is a composite mesh intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material. The device incorporates two distinct functional layers comprised of 1) a polytetrafluoroethylene (PTFE) knit mesh, laminated between 2) two porous synthetic bioabsorbable web layers. The permanent PTFE knit layer functions to provide strength when bridging a hernia or soft tissue defect. The porous bioabsorbable web layers provide a scaffold for tissue ingrowth and vascularization. The GORE® SYNECOR Preperitoneal Biomaterial is for single use only and is designed for preperitoneal placement and should be placed between tissue layers where ingrowth is desired.

GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include: -Hernia repair as suture line reinforcement -Muscle flap reinforcement -General tissue reconstructions

The subject GORE® BIO-A® Tissue Reinforcement is a bioabsorbable web structure that functions as a surgical mesh for soft tissue reinforcement while providing a scaffold for tissue ingrowth. It is used to reinforce soft tissue during the phases of wound healing by filling soft tissue deficits. It elicits a physiologic tissue response which fills the deficit with native tissue and gradually absorbs the device. The implanted GORE® BIO-A® Tissue Reinforcement is a porous, fibrous flat sheet web structure composed solely of synthetic bioabsorbable polyglycolide / trimethylene carbonate copolymer. In vivo studies indicate the bioabsorption process should be complete by six to seven months. The device is available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The device is sterilized by gamma irradiation validated to an SAL of 10-6. It is for single use only.

GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

The modified GORE® SEAMGUARD® Reinforcement possesses the same indications for use and fundamental scientific technology as the predicate GORE® SEAMGUARD® Reinforcement. The implantable device and loading carriers of the predicate GORE® SEAMGUARD® Reinforcement are being modified to permit the reinforcement material to be loaded onto the stapler and attach via adhesive-coated tabs that wrap around the side/back of the cartridge/anvil jaws of a surgical stapling device, in lieu of attaching a fully-coated device surface to the top surfaces of the cartridge/anvil jaws, to minimize the impact of the surface topography of surgical staplers in establishing compatible device fit. The implantable materials of the modified GORE® SEAMGUARD® Reinforcement and predicate GORE® SEAMGUARD® Reinforcement are the same bioabsorbable PGA:TMC. Both utilize the same bioabsorbable PLA:TMC adhesive to secure the device onto the jaws of a surgical stapler.

The GORE® BIO-A® Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mob's surgery, post laser surgery, podiatic, wound dehiscence), trauma wounds (abrasions, second degree burns, skin tears) and draining wounds.

GORE® BIO-A® Wound Matrix device is a tailorable, porous, bioabsorbable material matrix that provides a scaffold for cellular infiltration and vascularization. The device permits the ingress of cells and soft tissue formation into the defect space/wound bed. GORE® BIO-A® Wound Matrix is a porous fibrous structure composed solely of a synthetic copolymer comprised of polyglycolic acid and trimethylene carbonate (PGA:TMC).