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

abbott medical australia pty ltd - 42417 - cardiac sizing catheter - a triple lumen balloon catheter with three (3) radiopaque marker bands located inside the balloon to allow for radiographic measurement. the center of the balloon contains a pair of marker bands 0.4 mm apart (inside to inside), and one (1) marker band 15 mm proximal of that pair (15 mm from the proximal edge of the pair of marker bands). the amplatzer sizing balloon ii is designed to measure cardiovascular structures. sizing can be accomplished in two ways: radiographically or echocardiographically. the amplatzer sizing balloon ii is indicated for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important in selecting the appropriately sized occluder device.

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

abbott medical australia pty ltd - 45418 - cardiac occluder - a self-expanding nitinol mesh, double-disc occlusion device for use in atrial septal defects. the 2 discs are connected by a short waist with a waist diameter that corresponds to the atrial defect size. to increase its closing ability, the device is filled with polyester fabric that is securely sewn to each disc by a polyester thread. radiopaque marker bands at each end of the device provide visualization under fluoroscopy. the amplatzer septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects (asds) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration. patients indicated for asd closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular (rv) volume overload (ie, 1.5:1 degree of left-to-right shunt or rv enlargement).

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

abbott medical australia pty ltd - 45418 - cardiac occluder - a self-expanding nitinol mesh, double-disc occlusion device. the 2 discs are linked together by a short connecting waist allowing free motion of each disc. to increase its closing ability, the device is filled with polyester fabric that is securely sewn to each disc by a polyester thread. the amplatzer pfo occluder is a percutaneous, transcatheter occlusion device intended to close all types of pfos (i.e. classical as well as those with aneurysm of the septum) in patients with a history of stroke or transient ischemic attacks (tias) diagnosed by echocardiography with right-to-left shunting during the valsalva maneuver.

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

abbott medical australia pty ltd - 45418 - cardiac occluder - a self expandable, double disc device made from a nitinol wire mesh. the two discs are linked together by a short connecting waist. in order to increase its closing ability, the discs are filled with polyester fabric. the polyester fabric is securely sewn to each disc by polyester thread. the amplatzer cribriform occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multi-fenestrated (cribriform) atrial septal defects. patients indicated for asd closure have echocardiographic evidence of fenestrated ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (i.e., 1.5:1 degree of left to right shunt or rv enlargement).

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

abbott medical australia pty ltd - 45418 - cardiac occluder - a self-expanding, nitinol mesh device made for the occlusion of a patent ductus arteriosus (pda). a retention skirt on the occluder?s aortic side provides secure positioning in the ampulla of the ductus. as the occluder is implanted, it expands outward and the wires push against the wall of the ductus. the amplatzer duct occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (pda).

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

abbott medical australia pty ltd - 45418 - cardiac occluder - the device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. polyester patches are sewn into both the lobe and disc to facilitate occlusion. the lobe has stabilizing wires to improve device placement and retention. the device has threaded screw attachments at each end for connection to the delivery and loading cables. the device has radiopaque markers at each end and at the stabilizing wires that permit visibility during fluoroscopy. the amplatzer amulet left atrial appendage occluder is a percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage (laa) in patients who have non-valvular atrial fibrillation.

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

abbott medical australia pty ltd - 48054 - neural-tissue electrical stimulation lead adaptor - the adapter is intended to connect a trial cable to a compatible trial stimulator.

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

abbott medical australia pty ltd - 57996 - implantable stimulator control magnet - the patient magnet is used to turn an external pulse generator (epg) or implanted pulse generator (ipg) on and off.

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

abbott medical australia pty ltd - 42410 - holder, cable/lead - the single use header connects to the external pulse generator (epg) and enables connection of the trial cable to the epg.

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

abbott medical australia pty ltd - 34827 - tunneller, ligament/tendon - the tunnelling tool is used to create a subcutaneous tunnel to route the lead to the ipg site.