Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

nam pharma sdn. bhd. - sulfadimidine sodium/sulfamethazine sodium; trimethoprim -

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

livanova australia pty ltd - 46849 - circulatory assist transseptal cannula - the function of the transseptal cannula set ? ef (62 cm or 72 cm length) is to aid in the insertion of the transseptal cannula and to transport blood from the left atrium into the circulatory support system when connected to accessory extracorporeal equipment. the transeptal cannula set ? ef 72 provides an extended length to enable cannulation in individuals with a longer torso, and to accommodate the increased distance to the left atrium when cannulation is necessary from the left femoral vein. the transseptal cannula set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary left ventricular bypass when connected to the tandemheart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

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

life systems medical pty ltd - 47248 - transseptal needle - the safesept transseptal guidewire? is a nitinol guidewire designed to cross the interatrial septum when supported by a transeptal introducer and be atraumatic when advanced unsupported into the left atrium. a radiopaque coil is positioned on the distal end of the device to provide fluoroscopic localization during the procedure. white printed markers are positioned on the proximal end of the device to provide approximate transseptal guidewire tip location relative to the needle tip. the safesept transseptal guidewire? is used in conjunction with a transseptal needle to create the primary puncture in the interatrial septum and to guide the needle, dilator, and introducer through the septum from the right side of the heart to the left side.

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

abbott medical australia pty ltd - 60385 - atrial septal defect sizing plate - to measure the diameter of a sizing balloon which is used to determine the atrial septal defect.

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

merit medical australia pty ltd - 47248 - transseptal needle - the transseptal needle is used to create the primary puncture in the interatrial septum when passing an introducer and/or catheter through the septum from the right side of the heart to the left side. the kit consists of an outer needle cannula and an inner stylet. the needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock. the stylet consists of a solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula. it is used in conjunction with a transseptal catheter and/or introducer to create the puncture in the atrial septum to allow left heart catheterization procedure to occur through the right atrium.

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

merit medical australia pty ltd - 47247 - transseptal access system - the braided transseptal sheath is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations in addition to providing support for positioning and maintaining the position of catheters at specific locations within the heart. the kit consists of a sheath, a dilator, and a j-tipped guidewire. the sheath has a radiopaque marker band, an atraumatic soft tip, and a lubricious coating. the dilator has a tapered tip. for the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal puncture.

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

abbott medical australia pty ltd - 60385 - atrial septal defect sizing plate - to measure the diameter of a sizing balloon which is used to determine the atrial septal defect.

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

intermed medical pty ltd - 46397 - nasal septal button - intended to be used for non-surgical closure of septal perforations.

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

precise medical supplies pty ltd - 46397 - nasal septal button - intended to be used for temporary non-surgical closure of nasal septal perforations. the device is a single-use invasive device intended to be used in contact with the interior nasal cavity, the septum and the mucosal membrane, more specifically. the device is intended to be used up to 29 days (short term), however the duration of patient body contact can be long term (>29 days) as possible repeat applications with new devices on a patient are foreseen.

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

main medical pty ltd - 46397 - nasal septal button - nasal septal button used to occlude a perforation of the septum.