Australia - engelsk - 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 - engelsk - 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.

Spania - spansk - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

sanofi aventis s.a. - amiodarona hidrocloruro - comprimido - 200 mg - amiodarona hidrocloruro 200 mg - amiodarona

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

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - it consists of eptfe & fep, supported by nitinol wire along its external surface. a sleeve constrains the endoprosthesis on the leading end of the delivery catheter. deployment initiates from the trunk end of the delivery catheter, which is supplied with the endoprosthesis. after deployment, the eptfe/fep sleeve remains in situ between the endoprosthesis and the vessel wall 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 extender endoprostheses are intended to be used after deployment of the gore? excluder? aaa endoprosthe

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

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - the contralateral leg endoprosthesis consists of eptfe and fep, supported by nitinol wire along its external surface. 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 extender endoprostheses are intended to be used after deployment of the gore? excluder? aaa en

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

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - it consists of eptfe & fep, supported by nitinol wire along its external surface. a radiopaque marker denotes the recommended minimum overlap with the iliac limb of the excluder endoprosthesis. a sleeve constrains the endoprosthesis on the leading end of the delivery catheter. deployment initiates from the aortic end of the delivery catheter, which is supplied with the endoprosthesis. after deployment, the eptfe/fep sleeve remains in situ between the endoprosthesis and the vessel wall 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 a

Australia - engelsk - 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 - engelsk - 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 - engelsk - 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.