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

boston scientific pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - the synergy xd everolimus-eluting platinum chromium coronary stent system is mounted on a balloon expandable delivery catheter, is inserted percutaneously and advanced through the vasculature to the site of the lesion. the balloon is then inflated to expand the stent to the appropriate diameter. finally, the balloon is deflated and the balloon catheter removed, leaving the stent in position. the synergy xd stent system is intended to improve luminal diameter due to discrete, de novo native coronary artery stenosis in patients with symptomatic ischemic heart disease; including those with acute coronary syndromes (acute myocardial infarction and unstable angina), diabetes mellitus, renal failure or who are at a high risk of bleeding.

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

microport crm pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - the product is a balloon expandable stent with grooves on the outer surface of stent struts. the grooves are coated with a biodegradable drug (rapamycin)/polymer(dl-pla) matrix. the delivery system is a rapid exchange (rx) balloon catheter with effective working length of 140 cm. the firehawk rapamycin target eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions length ? 60 mm with reference vessel diameters of ? 2.25 to ? 4.0 mm.

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

boston scientific pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - the synergy megatron everolimus-eluting platinum chromium coronary stent system is mounted on a balloon expandable delivery catheter, is inserted percutaneously and advanced through the vasculature to the site of the lesion. the balloon is then inflated to expand the stent to the appropriate diameter. finally, the balloon is deflated and the balloon catheter removed, leaving the stent in position. the synergy megatron stent system is intended to improve luminal diameter due to discrete, de novo native coronary artery stenosis in patients with symptomatic ischemic heart disease; including those with acute coronary syndromes (acute myocardial infarction and unstable angina), diabetes mellitus, renal failure or who are at a high risk of bleeding. the synergy megatron stent system is also indicated for use in the following coronary lesion types: ? bifurcation ? ostial ? unprotected left main ? total occlusion ? in-stent restenosis ? saphenous vein graft ? multi-vessel disease the treated lesion length should be less than the nominal stent length with a reference vessel diameter of 3.50 mm - 5.00 mm.

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

microport crm pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - the product is a device/drug combination product consisting of a) a stent coated with rapamycin in a biodegradable polymer which filled in grooves on the outer surface of stent struts; and b)a rapid exchange (rx) delivery catheter. the stent is left in the vessel to permanently support the vessel. rapamycin is abluminal on stent struts and is slowly eluted to inhibit proliferation of smooth muscle cells. the coating will degrade and eventually the stent becomes a metal stent. the firehawk liberty? rapamycin target eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ? 60 mm) with reference vessel diameters of ? 2.25 to ? 4.0 mm.

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

biotronik australia pty ltd - 60910 - coronary venous pacing lead - in combination with a compatible implantable triple-chamber pacemaker or icd, this lead is indicated for the following: ? permanent, transvenous implantation in the coronary venous system via the coronary sinus of the left side of the heart ? permanent sensing and pacing of the left ventricle left ventricular pacing is indicated for patients who need ventricular resynchronization. it can also be an alternative if the use of ventricular endocardial leads is contraindicated due to an artificial tricuspid valve.

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

biotronik australia pty ltd - 60910 - coronary venous pacing lead - in combination with a compatible implantable triple-chamber pacemaker or icd, this lead is indicated for the following: ? permanent, transvenous implantation in the coronary venous system via the coronary sinus of the left side of the heart ?permanent sensing and pacing of the left ventricle left ventricular pacing is indicated for patients who need ventricular resynchronization. it can also be an alternative if the use of ventricular endocardial leads is contraindicated due to an artificial tricuspid valve.

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

medtronic australasia pty ltd - 62218 - coronary angioplasty balloon catheter, drug-eluting - the prevail paclitaxel-coated ptca balloon catheter is intended for percutaneous transluminal coronary angioplasty (ptca) in the coronary arteries with a vessel diameter from 2.0 mm to 4.0 mm to treat de novo lesions, in-stent restenosis (isr), and small vessel disease (svd).

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - bovine rotavirus (ncdv); clostridium perfringens type c toxoid; escherichia coli k99 pilus antigens; clostridium perfringens type d toxoid; bovine coronavirus (inactivated) - misc. vaccines or anti sera - bovine rotavirus (ncdv) biological-virus active 1.0 rp; clostridium perfringens type c toxoid vaccine-toxoid active 10.0 iu/ml; escherichia coli k99 pilus antigens vaccine-microbial active 1.0 rp; clostridium perfringens type d toxoid vaccine-toxoid active 2.0 iu/ml; bovine coronavirus (inactivated) vaccine-viral active 1.0 rp - immunotherapy - cow | healthy pregnant heifer | bovine | female cattle - bovine rotaviruses | neonatal calf diarrhea | neonatal enterotoxemia | raise colostral antibodies | against bovine rotavirus and | coronavirus | enterotoxigenic e.coli pilus | g6 and g10 | type k99

New Zealand - English - Ministry for Primary Industries

schering-plough animal health limited - bovine rotavirus (inactivated); bovine coronavirus (inactivated); escherichia coli k99 (pili) - bovine rotavirus (inactivated) 0 vaccine; bovine coronavirus (inactivated) 0 vaccine; escherichia coli k99 (pili) 0 vaccine - vaccine

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

vistamed pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - coronary angioplasty catheter manufactured by the balton company is a ?rapid exchange? catheter with a high pressure balloon near the distal tip. the distal section of the catheter is dual lumen. the outer lumen is used for inflation of the balloon, and the inner lumen is used for guide wire (.014? / 0.36 mm). the proximal section of the catheter is a single-lumen. catheter includes a radiopaque markers aids in the precision placement of the catheter?s balloon in a vessel. for improving coronary luminal diameter in the following patients with symptomatic coronary vessels disease caused by de novo atherosclerotic changes or restenosis in coronary arteries (length ? 40 mm), with reference diameter of the vessel from 1.25 to 7.0 mm.