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The GuardianTM burr hole cover system is intended for use following cranial surgery as an implantable 14-mm (0.55-in) burr hole cover for the skull. It can also be used to secure a lead with a 1.29-mm (0.051-in) or 1.39-mm (0.055-in) diameter

The GuardianTM burr hole cover system is used to close a cranial burr hole and secure an implanted, compatible lead, when applicable. The burr hole cover system is nonpyrogenic and has three main features: base, clip, and cover. The base is intended for burr holes with a 14-mm (0.55-in) diameter. It contains two grooved slots to hold a lead in place. The clip fits into the base to hold the lead. The locking mechanism temporarily holds a lead in place before the burr hole cover is secured. The cover snaps onto the base, closing the burr hole and locking a lead in place.

The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™M Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in one size (18F) and two lengths (30cm and 50cm). The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the length and packaging of the current device. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a quiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm. The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the current design to improve the manufacturability and to increase the product shelf life. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-1 leads or to SJ4 leads. The Merlin PSA Patient Cable Adapter EX3170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3170 Cable Adapter can connect to the Models 4051/4051A disposable patient cables for IS-1 leads or to the Model 4161 disposable patient cable for SJ4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads. The Merlin PSA "M" Adapter Model EX3180 is intended to connect the Merlin PSA to the twochannel Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292 cable connects to implantable pacing leads. Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.

The Merlin PSA Patient cable, Model EX3150 is an accessory to the Merlin PSA EX3100 system, which is intended to assess the pacing and sensing performance of the lead system prior to pulse generator implantation, or during invasive lead system troubleshooting. The PSA Patient cable is intended to connect one to three implanted leads to the Merlin PSA EX3100, which is the patient interface part of the PSA product. The PSA Patient cable is the interface between the implanted leads and the PSA unit. The ODU connector end of the cable is connected to the Merlin PSA and the Alligator clip end is connected to the leads. The PSA Patient cable is re-sterilizable. Patient Cable Adapters - Merlin PSA Cable Adapter EX 3170, Merlin PSA "M" Adapter EX 3180 connects the Merlin PSA to commonly used PSA patient cables Merlin PSA Cable Adapter EX3170 connects to the currently marketed disposable surgical cables 4051/4051A and 4161. Merlin PSA "M" Adapter EX3180 connects to the Medtronic Model 2292 patient cable.