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

aa-med pty ltd - 61533 - interspinous spinal fixation implant - the spinal simplicity minuteman implants are posterior, non-pedicle supplemental fixation devices, intended for use at a single level in the non-cervical spine (t1-s1). it is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: ? degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); ? spondylolisthesis; ? trauma (i.e., fracture or dislocation); and/or ? tumor. the minuteman implants are intended for use with bone graft material and is not intended for standalone use. the minuteman implants may be implanted via a minimally invasive posterior approach (t1-s1) or a minimally invasive lateral approach (l1- s1)*. *note: the minuteman g3-r implant may not be inserted using a posterior approach.

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

aa-med pty ltd - 46352 - stent, vascular, intracranial - the credo? stent is indicated to increase the vessel diameter of intracranial arteries that are suitable for and accessible to the system (stent with pta balloon catheter) inpatients: ? with arteriosclerotic (probable according to clinical, anamnestic or laboratory chemical testing) vessel constrictions (high-grade intracranial stenoses > 70%) with significant circulatory disturbance (haemodynamic infarct pattern and indication of restricted collaterals) in spite of intensive medication therapy, ? with recurrent symptoms in spite of antiaggregation therapy(therapy-refractory) after at least two events (stroke), ? aged 18 to 80, ? whose last stroke occurred at least 7 days before and in whom the impairment after stroke has a rating of 3 or lesson the modified rankin scale (mrs) at the time of treatment. or ? with evidence of intracranial large vassal occlusion (lvo) ? over 18 years old, -with acute persistent vascular occlusion due to high-grade intracranial stenosis for which alternative therapy concepts are not considered or fail ? with suspected underlying stenosis of the occluded artery, which is suitable for pta and stenting according to the treating physician's assessment, ? with small to moderate infarct core prior to initiation of thromectomy (ct aspects 6-10. dwi lesion < 70ml)

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

aa-med pty ltd - 46352 - stent, vascular, intracranial - used in combination with the neurospeed? pta balloon catheter, the credo? heal stent is indicated to increase the vessel diameter of intracranial arteries (for example the ica, mca, va/v4, ba) that are suitable for and accessible to the system (stent with pta balloon catheter) in patients: ? with arteriosclerotic (probable according to clinical, anamnestic or laboratory chemical testing) vessel constrictions (high-grade intracranial stenoses > 70 %) with significant circulatory disturbance (haemodynamic infarct pattern and indication of restricted collaterals) in spite of intensive medication therapy, ? with recurrent symptoms in spite of antiaggregation therapy (therapy-refractory) after at least two events (stroke), ? over 18 years old, ? whose last stroke occurred at least 7 days before and in whom the impairment after stroke has a rating of 3 or less on the modified rankin scale (mrs) at the time of treatment. or ? with evidence of intracranial large vessel occlusion (lvo), ? over 18 years old, ? with acute persistent vascular occlusion due to high-grade intracranial stenosis for which alternative therapy concepts are not considered or fail, ? with suspected underlying stenosis of the occluded artery, which is suitable for pta and stenting according to the treating physician's assessment, ? with small to moderate infarct core prior to initiation of thrombectomy (ct aspects 6-10, dwi lesion < 70 ml).

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

aa-med pty ltd - 34994 - dialysate delivery system, haemodialysis, single patient - a hemodialysis machine used on patients having acute or chronic renal failure which is composed of a hydralic unit for dialysate & an extracorporeal blood circuit.

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

aa-med pty ltd - 34999 - tubing set, dialysis/haemodialysis - a sterie disposable set for use with the haemodialysis machine to enable the administration of haemodialysis to patients.

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

aa-med pty ltd - 47841 - soft corrective contact lens, daily-disposable - a soft ophthalmic lens intended to be worn daily to correct refractive vision conditions (e.g. myopia, hyperopia, astigmatism, presbyopia). the device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes, it may include an ultraviolet blocker. the device is made of various synthetic polymer materials, the main being hydrophilic (e.g. hydrogel).

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

aa-med pty ltd - 44796 - clinical measurer, ruler - the atriclip gillinov-cosgrove selection guide is intended to be used as an accessory to the atriclip laa exclusion system with preloaded gillinov-cosgrove clip. the selection guide helps the medical practitioner select the correct size gillinov-cosgrove clip for the patient.

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

aa-med pty ltd - 11588 - alarm, enuresis - intended for the treatment of night-time bedwetting through the activiation of an alarm when a small quantity of urine is detected.

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

aa-med pty ltd - 63386 - x-ray image interpretive software - transpara is intended for use as a concurrent reading aid for radiologists during interpretation of 2d and 3d mammograms of asymptomatic women to identify regions suspicious for breast cancer. output of the device contains region-based scores indicating the likelihood that cancer is present in specific regions and an overall score indicating the likelihood that cancer is present on the mammogram. patient management decisions should not be made solely on the basis of analysis by transpara.

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

aa-med pty ltd - 46644 - craniofacial fixation plate kit, non-biodegradable - a collection of titanium plates and bone screws, of various shapes/sizes, that are implanted onto fractured craniofacial bone to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. the device may also be used for craniofacial reconstructive procedures.