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

abbott medical australia pty ltd - 35852 - defibrillator, implantable, automatic - the unify assura cd3361-40c is a cardiac resynchronisation therapy device with rf telemetry and it monitors and regulates the patient?s heart rate by providing ventricular tachyarrhythmia therapy and single site pacing. it features an is-1/df-1 device header and parylene coating. the unify assura cd3361-40c is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. cardiac resynchronization therapy devices (crt-ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. also at/af detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of af.

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

abbott medical australia pty ltd - 35852 - defibrillator, implantable, automatic - the unify assura cd3361-40qc is a cardiac resynchronisation therapy device with rf telemetry and it monitors and regulates the patient?s heart rate by providing ventricular tachyarrhythmia therapy and single site pacing. it features a df4 device header and parylene coating. the unify assura cd3361-40qc is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. cardiac resynchronization therapy devices (crt-ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. also at/af detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of af.

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

d.d.d. limited - docosanol - cream - 100 milligram(s)/gram - antivirals; docosanol

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

d.d.d. limited - strong ammonia solution; phenol, liquefied; ammonia solution, aramatic - cream - 0.270 +6.04 +0.494 percent weight/weight - other dermatologicals

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

d.d.d. limited - dimeticone, activated - oral suspension - 21 mg/ 2.5 millilitre(s) - other drugs for functional gastrointestinal disorders; silicones

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

stryker australia pty ltd - 38161 - spinal cage - the lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (ddd) at one level or two contiguous levels. ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. the ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level(s). these patients should be skeletally mature and have six months of nonoperative therapy. additionally, the lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. the lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. the cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (ddd) at one level or two contiguous levels. these patients should be skeletally mature and have had six weeks of non-operative treatment. the cervical implants are also to be used with supplemental fixation; the hyperlordotic cervical implants (i.e., greater than or equal to 10?) are required to be used with an anterior cervical plate as the form of supplemental fixation.

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

stryker australia pty ltd - 61324 - bone-screw internal spinal fixation system, sterile - the spinal system is a non-cervical, pedicle screw fixation device for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. it is also indicated for the treatment of severe spondylolisthesis of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (ddd ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

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

matrix medical innovations pty ltd - 37272 - fixation device, internal, spine, construct - the carboclear pedicle screw system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities and ddd of the thoracolumbar and sacral spine. also intended for use in for non-cervical, posterior pedicle screw fixation for skeletally mature patients with severe spondylolisthesis at the l5-s1 vertebral joint, who are receiving fusions using autogenous bone graft, with the device attached to the lumbar and sacral spine (l3 to s1), and for whom the device is intended to be removed after the attainment of a solid fusion.

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

emergo asia pacific pty ltd t/a emergo australia - 46653 - spinal fixation plate, non-biodegradable - the system is intended for anterior screw fixation to the cervical spine (c2-c7). the system is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusion in patients with: - ddd (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - spondylolisthesis - trauma (i.e. fractures or dislocations) - tumors - deformity (defined as kyphosis, lordosis or scoliosis), - pseudarthrosis - failed previous fusion - spinal stenosis

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

emergo asia pacific pty ltd t/a emergo australia - 60762 - polymeric spinal fusion cage, non-sterile - the system is indicated for use in skeletally mature patients with degenerative disc disease (ddd) of the cervical spine with accompanying radicular symptoms at one disc level. ddd is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. the system is used to facilitate intervertebral body fusion in the cervical spine at the c3 to c7 disc levels using autograft bone. the system is to be used with supplemental fixation. patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.