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

boston scientific pty ltd - 36007 - stimulator, electrical, analgesic, spinal cord - the system is intended to treat chronic pain by electrically stimulating the spinal cord. the multi-channel, multi-electrode capability provides flexibility and easy of programming. the ipg is controlled by a remote control and can be engaged by a clinician programmer using proprietary programming software. ipg is also packaged with: torque wrench, tunnelling tool assembly, ipg pocket template, port plugs the precision novi implantable pulse generator (ipg) system is intended to treat chronic pain by electrically stimulating the spinal cord.

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

boston scientific pty ltd - 48054 - neural-tissue electrical stimulation lead adaptor - the precision m8 adaptor is designed to connect medtronic leads to precision or precision spectra ipg when a medtronic spinal cord stimulator is being revised. the adaptor can be used as a sterile permanent implant or used in the trial procedure to connect medtronic leads to bsn external trial stimulator (ets). a set screw mechanism is provided to retain the medtronic lead. the precision? m8 adapter is a 1 x 8 in-line connector that is designed to connect specific medtronic? leads to the boston scientific scs implantable pulse generators, or cables, leads, and lead extensions, as part of a spinal cord stimulation procedure.

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

boston scientific pty ltd - 36362 - remote control, cordless - the external and implantable stimulator communicates with and controlled by the patient remote control via a wireless link. the patient remote control has stimulation on/off functions; stimulation amplitude and other (optional) parameters; stimulation delivery areas and individualized stimulation therapy programs. the precision scs system with multiwave technology remote control is a hand-held programmer for patient control of the precision scs system with multiwave technology implantable and external pulse generators which are intended for use in the treatment of patients with chronic pain.

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

boston scientific pty ltd - 36007 - stimulator, electrical, analgesic, spinal cord - the external trial stimulator (ets) communicates with and controlled by the patient remote control and clinician programmer via a wireless link. the ets is connected to the proximal end of the either a single or dual percutaneous in-line lead that is placed in the spinal epidural space. electrodes on the lead deliver electrical energy from the ets to the spinal cord which can mask pain in the targeted area for the patient. the precision scs system with multiwave technology trial stimulator is intended to be used during a screening trial to assess the efficacy of spinal cord stimulation in the treatment of patients with chronic pain.

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

emergo asia pacific pty ltd t/a emergo australia - 35095 - surgical drill guide, reusable - a medical device that allows clinicians to drill through a surgical guide to create an osteotomy for product placement with the precision and accuracy as designed. the sleeve is embedded into a surgical guide to be used in conjunction with the surgical guide handles.

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

gdc precision pty ltd - 46976 - surgical mallet head - a device used to manually impart a force on another object during surgical intervention.

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

emergo asia pacific pty ltd t/a emergo australia - 35095 - surgical drill guide, reusable - a medical device that allows clinicians to drill through a surgical guide to create an osteotomy for product placement with the precision and accuracy as designed. the kit consists of 4 guide handles with inserts attached on each end. each insert has an opening that matches the diameter of our surgical drills. the insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

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

emergo asia pacific pty ltd t/a emergo australia - 62851 - surgical instrument holder, reusable - this device is used for precision cone fitting during root canal procedures.

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

boston scientific pty ltd - 64970 - analgesic spinal cord electrical stimulation system pulse generator implantable - the kit consists of lpg, lpg port plugs and surgical accessories. the ipg is intended to treat chronic pain by electrically stimulating the spinal cord. it is a rechargeable device controlled by a handheld remote control, and can be engaged by a clinician programmer for programming. periodically, the ipg battery requires replenishing with an external rf charging device. the boston scientific spinal cord stimulator system is indicated as an aid in the management of chronic intractable pain.

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

brainlab australia pty ltd - 38723 - robot, surgical, navigation unit - intended to be an intra-operative image guided localization system to enable precision surgery. indicated for medical conditions where the use of stereotactic surgery may be appropriate.