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

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - xience skypoint is a medical device that will deliver and deploy a balloon-expandable, drug-coated 605 stent in de novo and restenotic native arteries to improve coronary artery luminal diameter.the mode of action is mechanical opening of stenosed vessels. the radiopaque balloon markers are used to position the stent in the target lesion. the balloon is then inflated to deploy the stent, followed by withdrawal of the delivery system once stent position and full deployment have been confirmed. the xience skypoint everolimus eluting coronary stent system is indicated for improving coronary artery luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. ? for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. ? for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%); for the treatment of elderly patients (age ? 65), and for treatment of both men and women. ? for treatment of patients with high bleeding risk (hbr) under dual anti-platelet therapy (dapt) as short as 28 days. ? for the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions (defined as coronary artery lesions with timi flow 0 and lasting longer than 3 months); and coronary artery bifurcation lesions. additional indication applicable for xience skypoint ((2.0 ? 4.0 mm, 8.0 - 38 mm) and (4.5 - 5.0 mm, 12 ? 33mm)): ? for the treatment of patients presenting with left main coronary artery lesions. in all cases for ? xience skypoint ((2.0 ? 4.0 mm, 8.0 - 38 mm) and (4.5 - 5.0 mm, 12 ? 33mm)): the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel diameter of ? 2.00 mm and ? 5.25 mm. ? xience skypoint (2.5 ? 4.0 mm, 48 mm): the treated lesion length should be less than the nominal stent length (48 mm) with a reference vessel diameter of ? 2.50 mm and ? 4.25 mm.

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

abbott medical australia pty ltd - 47805 - implantable cardiac monitor patient programmer - the mymerlin mobile application (app) is a software application intended for installation on mobile device (android). the app uses bluetooth technology to communicate with compatible abbott's insertable cardiac monitor (icm). the app can be used by patients to activate recordings in the implanted device and wirelessly transmit data for physician and clinician review. the mymerlin mobile application (app) is intended for people who have a jot dx insertable cardiac monitor (icm) or confirm rx icm and access to a mobile device. the app allows the patient to activate recordings in the implanted device and wirelessly transmit data for physician and clinician review.

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

abbott medical australia pty ltd - 47805 - implantable cardiac monitor patient programmer - the mymerlin mobile application (app) is a software application intended for installation on mobile device (ios). the app uses bluetooth technology to communicate with compatible abbott's insertable cardiac monitor (icm). the app can be used by patients to activate recordings in the implanted device and wirelessly transmit data for physician and clinician review. the mymerlin mobile application (app) is intended for people who have a jot dx insertable cardiac monitor (icm) or confirm rx icm and access to a mobile device. the app allows the patient to activate recordings in the implanted device and wirelessly transmit data for physician and clinician review.

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

abbott medical australia pty ltd - 48054 - neural-tissue electrical stimulation lead adaptor - the adapter is designed to connect a non-st jude medical implanted neuromodulation lead or extension to an 8-channel port of a st. jude medical implantable pulse generator system or st jude medical trial system.

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

abbott medical australia pty ltd - 48054 - neural-tissue electrical stimulation lead adaptor - the is-1 pocket adapter is designed to adapt a medtronic extension (series 7471, 7472, 7482, 7489, 7495, 7496 and 7498) to a st. jude medical neurostimulator.

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

abbott medical australia pty ltd - 60246 - mitral transcatheter heart valve bioprosthesis - the tendyne mitral valve is a bioprothesis designed for transapical implantation within the native mitral valve. the valve has three pericardial leaflets sewn onto a circular, self-expanding frame. the inner frame is sewn inside a self-expanding outer frame. the outer frame helps orient the prosthesis inside the native mitral valve. indicated for the treatment of the native mitral valve without prior mitral valve intervention in patients with symptomatic (nyha class iii or iv) severe mitral valve regurgitation, a life expectancy between 1 and 5 years, left ventricular ejection fraction (lvef) ? 30%, left ventricular end-diastolic dimension (lvedd) ? 7.0 cm, who do not have severe mitral annular calcification and are deemed not suitable for surgical repair or replacement or transcatheter mitral repair who have secondary mr and are symptomatic despite maximally-tolerated guideline directed medical therapy (including cardiac resynchronization therapy, if indicated).

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

abbott medical australia pty ltd - 61680 - implantable cardiac device management application software - the mymerlinpulse mobile app uses bluetooth low energy (le) technology in the mobile device to communicate with patient's implanted heart device. the app also uses an internet connection through a wi-fi or cellular network to send information about patient's implanted heart device to healthcare provider for remote care. the mymerlinpulse mobile application is intended for use by people who have an abbott medical implanted heart device and access to a mobile device. the app provides remote monitoring capability of the implanted heart device by transmitting information from patient's implanted heart device to the patient's healthcare provider.

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

abbott medical australia pty ltd - 61680 - implantable cardiac device management application software - the mymerlinpulse mobile app uses bluetooth low energy (le) technology in the mobile device to communicate with patient's implanted heart device. the app also uses an internet connection through a wi-fi or cellular network to send information about patient's implanted heart device to healthcare provider for remote care. the mymerlinpulse mobile application is intended for use by people who have an abbott medical implanted heart device and access to a mobile device. the app provides remote monitoring capability of the implanted heart device by transmitting information from patient's implanted heart device to patient's healthcare provider.

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

abbott medical australia pty ltd - 40761 - ultrasound system, imaging, general-purpose - this device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

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

abbott medical australia pty ltd - 37307 - brain electrical stimulation system, antitremor - the extensions are designed to connect the lead to the ipg. one end is designed to receive the proximal end of the lead, and the opposite end is designed for insertion and connection with the ipg. the 8-channel infinity extensions connect to 8-channel infinity leads. infinity extensions have coloured bands that can help during implantation to differentiate between the right and left sides of the body. the devices (except model 6373) are mr conditional. deep brain stimulation extensions are intended to connect the leads to implantable pulse generators.