Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - trunk-ipsilateral leg endoprostheses consists of eptfe and fep, supported by nitinol wire along its external surface. nitinol anchors and an eptfe/fep sealing cuff are located at the aortic end of the trunk. an eptfe sleeve is used to constrain the endoprostheses on the leading edge of the delivery catheter. deployment is initiated from the leading (aortic) end and proceeds toward the trailing (iliac) end of the delivery catheter, which is supplied with the endoprosthesis. the gore? excluder? aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as described below: ? adequate iliac/femoral access ? infrarenal aortic neck treatment diameter range of 19 ? 32mm and a minimum aortic neck length of 15mm ? proximal aortic neck angulation ? 60? ? iliac artery treatment diameter range of 8 - 25mm and iliac distal vessel seal zone length of at least 10mm the aortic and iliac exte

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 45418 - cardiac occluder - a platinum-filled nickel-titanium wire frame covered with hydrophilic coated eptfe and a catheter delivery system. when fully deployed, the occluder assumes a left and right atrial disc configuration to bridge septal defects. the gore cardioform septal occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter closure of atrial septal defects (asds), such as ostium secundrum and patent foramen ovale (pfos).

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 48060 - descending thoracic aorta endovascular stent-graft - an eptfe tube reinforced with cptfe/fep film that is supported by a self-expanding nitinol wire-frame (stent) along its external surface. it has radiopaque gold marker bands to aid in positioning of the endoprosthesis. implantation is by means of a delivery catheter. the gore tag thoracic endoprosthesis is intended for endovascular repair of the descending thoracic aorta.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 66384 - aortic endovascular implant post-dilation balloon catheter - a compliant, tri-lobed polyurethane balloon catheter with three balloons mounted on leading end of the multi-lumen catheter shaft. fitted with luer lock port and lumens for inflation. the lobed design allows for inflation without complete aortic blood flow blockage. radiopaque markers indicate balloon edges. guidewire lumen allows over-the-wire access. guidewire lumen?s trailing end has a tuohy-borst valve and is affixed with a flushing/guidewire port with luer lock. the gore tri-lobe balloon catheter is intended to assist in the dilatation of self-expanding endoprostheses in the aorta.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - the conformable aortic extender component (excc ae) is intended to provide proximal extension to the conformable trunk-ipsilateral leg component if additional seal is needed to facilitate exclusion of the aaa from blood flow. the excc ae has individual stent rings as body rows, similar to the excc trunk-ipsilateral leg device. the aortic extender endoprostheses are intended to be used after deployment of the gore? excluder? conformable aaa endoprosthesis. these extensions are intended to be used when additional length and / or sealing for aneurysmal exclusion is desired.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 44688 - mesh, polymeric, biodegradable - rectangular sheets of porous, fibrous mesh. the instructions for use indicate that this device is a tailorable, synthetic, bioabsorbable material intended to be a temporary bridge of defects until the bioabsorbable nature of the device allows the body to fill the defect with native tissue. in repairs requiring high strength, a permanent overlay patch is strongly recommended. the gore bio-a tissue reinforcement is intended for use in the reinforcement of soft tissue.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 47932 - multiple peripheral arteries stent - a self expanding endoluminal endoprosthesis with an eptfe lining and external nitinol support. its surface is modified with covalently bound bioactive heparin. it is provided compressed and attached to a dual lumen delivery catheter. the larger central catheter lumen is used for flushing and guidewire introduction. the smaller lumen contains elements of the deployment mechanism. 2 radiopaque bands are attached to the catheter shaft, marking the ends of the compressed endoprosthesis the gore viabahn endoprosthesis with propaten bioactive surface is a flexible, self-expanding endoluminal prosthesis for endovascular grafting of peripheral arteries.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 62455 - portosystemic needle set - the gore tips set consists of the gore? tips sheath and the gore tips needle. the gore? tips sheath consists of a flexible introducer sheath with a hemostatic valve and a dilator. the introducer sheath includes an inner ptfe layer, a stainless steel coil and an outer jacket. the gore tips needle consists of a stainless steel hollow shaft and a guiding catheter. the needle handle has a direction indicator to allow identification of the leading end curvature direction. the device is intended to be used as a transjugular intrahepatic portosystemic shunt access set, or tips set.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 17467 - suture, polytetrafluoroethylene - a thread with or without a needle to join the edges of a wound or incision by stitching

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 31744 - cardiovascular patch, synthetic - a thread with or without a needle plus pledgets. to augment or repair damaged membranes in the heart.