Австралія - англійська - Department of Health (Therapeutic Goods Administration)

abbott medical australia pty ltd - 47487 - medical device electrical cable, general purpose - pressure transducer cables are intended to connect the centrimag console with the corresponding commercially available pressure transducers.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 57790 - mitral valve clip - the triclip g4 implant is a percutaneously implanted mechanical implant that grasps and coapts the tricuspid valve leaflets resulting in fixed approximation of the tricuspid leaflets throughout the cardiac cycle.the triclip g4 implant comes preloaded on a triclip delivery system (tcds).the tcds is used to advance and manipulate the implant for proper positioning and placement on the tricuspid valve leaflets.the tcds has a hydrophilic coating and is designed to deploy the implant in multiple step the triclip? g4 system is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. the triclip device is indicated for patients with severe tricuspid regurgitation who are symptomatic despite medical therapy with valve anatomies that are conducive for transcatheter repair and who have been determined to be at high or greater estimated risk for tricuspid valve surgery by a heart team

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 17846 - catheter, intravascular, guiding - the triclip steerable guide catheter(tsgc) is used to introduce the triclip delivery system(tcds) into the right side of the heart. the tsgc is also used to position and orient the tcds to the appropriate location above the tricuspid valve. the dilator is used for the introduction of the tsgc into the femoral vein and right atrium.the outer surface of the tsgc has a hydrophilic coating. the triclip? g4 system is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. the triclip device is indicated for patients with severe tricuspid regurgitation who are symptomatic despite medical therapy with valve anatomies that are conducive for transcatheter repair and who have been determined to be at high or greater estimated risk for tricuspid valve surgery by a heart team

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 47490 - coronary optical coherence tomography system - optical coherence tomography component-based system and its software used with a compatible imaging catheter is intended for qualitative and quantitative evaluation of vascular morphology in the coronary arteries, as an adjunct to conventional angiographic procedure to provide an image of vessel lumen and wall structures, for imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedure. the system further computes and displays various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 35094 - catheter guide wire - the guide wire contains a 304v stainless steel core to yield the desired support and performance. the guide wire's hydrophilic distal end includes a series of tapered grinds and a parabolic grind which reduce diameter and stiffness of the distal core. the tip is j-shaped with a 14 g tip load. modified proximal end allows attachment of guide wire extension extending the working length to facilitate exchange of interventional devices. proximal and distal markers aid in gauging guide wire position. this guide wire is intended to facilitate delivery of catheter-based interventional devices during ptca and pta. this guide wire may be used with compatible stent devices during therapeutic procedures. the guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. it may also be used to cross or assist in crossing de novo chronic total coronary occlusions (cto). it is a single use device. not intended for use in the cerebral vasculature.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 35094 - catheter guide wire - a 304v stainless steel core yields desired support and performance. the hydrophilic distal end includes a series of tapered grinds and a parabolic grind to reduce the diameter and stiffness of the distal core. modified proximal end allows attachment of doc guide wire extension to facilitate exchange of interventional devices. proximal markers aid in gauging guide wire position relative to guiding catheter tip. distal radiopaque markers act as references in determining lesion length. this guide wire is intended to facilitate delivery of catheter-based interventional devices during ptca and pta. this guide wire may be used with compatible stent devices during therapeutic procedures. the guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. it may also be used to cross or assist in crossing de novo chronic total coronary occlusions (cto). it is a single use device. not intended for use in the cerebral vasculature.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

abbott medical australia pty ltd - 47491 - coronary optical coherence tomography system catheter - the dragonfly opstar? imaging catheter consists of two main assemblies: the catheter body and the internal rotating fiber optic imaging core. the catheter has an insertable length of 135 cm with a maximum diameter of 3.5 fr. it is a rapid-exchange (rx) design with a "monorail" tip, having 17 mm of guide wire engagement length. the catheter has a hydrophilic coating and is designed for compatibility with 0.014? (0.355 mm) steerable guide wires used during coronary interventional procedures. the dragonfly opstar? imaging catheter with the oct imaging system is intended for the visualization and imaging of coronary arteries during interventional procedures. the dragonfly opstar? imaging catheter and oct imaging system are intended: 1. for qualitative and quantitative evaluation of vascular morphology in the coronary arteries 2. as an adjunct to conventional angiographic procedure to provide an image of vessel lumen and wall structures 3. for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedure.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 58115 - peripheral vascular guidewire - the hi-torque peripheral guide wires are intended to facilitate navigation across vascular anatomies and structures in order to deliver diagnostic and therapeutic devices.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 53616 - bare-metal coronary artery stent - the graftmaster rx coronary stent graft is constructed using a sandwich technique, whereby an ultra-thin layer of expandable polytetrafluoroethylene (ptfe) is placed between two graftmaster stentswhich are then pre-mounted on a balloon catheter delivery system. the stents are fabricated from medical grade 316l stainless steel. the graftmaster delivery system is a rapid exchange co-axial design with the balloon and stent graft at the distal end of the catheter. the graftmaster rx is a balloon-expandable pre-mounted coronary stent graft for intraluminal chronic placement in coronary arteries or aorto-coronary bypass grafts for the treatment of: ?? acute coronary artery perforation ?? acute coronary artery rupture patients being considered for stent graft implantation should be acceptable for coronary artery bypass graft surgery, and / or for coronary balloon angioplasty with ischemic heart disease due to discrete de novo or restenotic native coronary lesions.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

abbott medical australia pty ltd - 47491 - coronary optical coherence tomography system catheter - kit box comprises: catheter, syringe & doc cover. catheter comprises two main assemblies & is a rapid-exchange (rx) design with a "minirail" tip. during image acquisition, fiber optic core of catheter rotates & is automatically retracted within catheter to obtain a 360o image of artery & a continuous pullback image of an arterial segment. syringe purges air from catheter. doc cover covers drive-motor & optical connector (doc) component of the oct imaging system. the dragonfly optis imaging catheter, in conjunction with the oct imaging system, the syringe and doc cover, are intended: 1. for qualitative and quantitative evaluation of vascular morphology in the coronary arteries 2. as an adjunct to conventional angiographic procedure to provide an image of vessel lumen and wall structures 3. for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedure. the individual components within the kit are sterile.