Australië - Engels - Department of Health (Therapeutic Goods Administration)

actavis pty ltd - pravastatin sodium -

Australië - Engels - Department of Health (Therapeutic Goods Administration)

life systems medical pty ltd - 35855 - catheter, cardiac, ablation - the device is prepared by inserting endoscope into catheter, then placed into left atrium via std transeptal puncture & guided to the pv orifice using a sheath. balloon is inflated & endoscope within allows physician to visualise & perfect balloon/tissue contact. lesion generator within the catheter, used with laser, delivers arc shaped patterns of light energy into atrial or ostial wall under endoscopic guidance. ir laser energy raises tissue temp. resulting in thermal ablation of target tissue the easac catheter is a single use disposable device for the isolation of pulmonary veins to be used in the treatment of af. it is introduced percutaneously in the setting of an electrophysiology or cathererization laboratory. the easac catheter is a component of the easac system which is intended to be used to direct light energy in the antrum of the pulmonary veins to create conduction block as a treatment for atrial fibrillation in patients aged 18 or older.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 36777 - suction unit, electric powered - a reusable compact pv console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and led indicators for device operational status. the device is intended for use in atherectomy of the peripheral vasculature and in breaking apart and removing calcified atherosclerotic plaque from upper and lower extremity peripheral arteries using differential cutting and orthogonal displacement of friction. it is not intended for use in carotid, iliac, or renal vasculature.