Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 47733 - cardiopulmonary bypass cannula, femoral - femoral access arterial cannula. wire-reinforced and thin-wall cannula with introducer that passes over a 0.038" (0.96 mm) guidewire. the clear proximal section is not reinforced to allow clamping and terminates in a barbed connector. the cannula includes two barium stripes on the tubing to aid in placement. it comes in 16, 18, and 20fr sizes for use in adults. edwards lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (? 6 hours) cardiopulmonary bypass. vessel access (venous or arterial) is left to the discretion of the physician. femoral access cannulae may be used in paediatric populations or adult populations based on flow rate requirements and individual patient anatomy.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 57790 - mitral valve clip - the implant system consists of the steerable catheter (outermost layer), the implant catheter (innermost layer), and the implant (implant model 10000ism). the implant system percutaneously delivers the implant to the valve via a femoral vein access using a transvenous approach. the implant is deployed and secured to the leaflets of the valve, acting as a filler in the regurgitant orifice. the primary components of the implant are the spacer, paddles, and clasps made from nitinol. the edwards pascal valve repair system is indicated for the percutaneous reconstruction of an insufficient mitral valve through tissue approximation. the pascal system - pascal ace implant system is part of the edwards pascal transcatheter valve repair system.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 60244 - mitral heart valve bioprosthesis - the mitris resilia mitral valve is a stented tri-leaflet prosthetic heart valve comprised of resilia bovine pericardial tissue. this low-profile valve is based on the edwards perimount valve design with a nitinol wire form. the valve is mounted on a retainer with a holder system attached to the valve. intended for use as a heart valve replacement. the device is indicated for patients who require replacement of their native or prosthetic mitral valve.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

edwards group pty ltd - 10500 - brush, - these brushes are intended to be used for general purpose cleaning such as surgical instruments before sterilisation. these devices are supplied non sterile and are reusable.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

edwards group pty ltd -

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

edwards group pty ltd - 33162 - detergent, - intended to be sprayed onto surgical instruments after use to dislodge/loosen/dissolve blood/protein and other bioburden. this product is supplied non-sterile

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

edwards group pty ltd -

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

edwards group pty ltd -

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

edwards group pty ltd -

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

edwards group pty ltd -