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The SJM Confirm® Implantable Cardiac Monitor is indicated for monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, shortness of breath, and patients who are at risk for other cardiac arrhythmias.

The SJM Confirm® Implantable Cardiac Monitor is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes that are used for sensing and a looping memory for storage of electrograms (EGM). The device is comprised of three main components: the implantable cardiac monitor (Model DM2100) and the external patient activator (Model DM2100A). The third component is the programmer the physician uses to communicate to the cardiac monitor and associated programmer software. The programmer is the legally marketed SJM Merlin PCS programmer Model 3650 (with Software Model 3330).

The St. Jude Medical™ CPS Direct™, Mediguide™ Enabled slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. The CPS Direct™, Mediguide Enabled slittable outer guide catheter are used with the Mediguide™ System to enable realtime tip positioning and navigation. The Mediguide™ system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, Mediguide™ Enabled slittable outer guide catheters can work with inner catheters as a system.

The St. Jude Medical CPS Direct MediGuide Enabled slittable outer guide catheter is made from PEBAX and reinforced with a stainless steel braid. The shaft has progressively decreasing durometers of PEBAX from the proximal to the distal end with a soft, atraumatic distal tip. The distal end is embedded with a sensor coil to enable device tip projection onto the MediGuide system and tungsten stripes for fluoroscopic visibility. The hub contains an integrated hemostasis valve and the proximal shaft is integrated into the hub creating a slit channel. The hub contains a sideport with extension tubing for contrast delivery, aspiration or saline flush using a 3-way stopcock. In addition, the hub contains a port for the connector cable.

The St. Jude Medical CPS Excel™ MediGuide Enabled™Guidewire is intended for use with the MediGuide™ System to enable real-time tip positioning and navigation within the coronary and peripheral vasculature (such as to facilitate left heart lead implantation). The MediGuide system is intended for use as an adjunct to fluoroscopy

The St. Jude Medical CPS Excel ™ , MediGuide Enabled ™ guidewire is a MediGuide enabled guidewire with a hydrophilic coating. The CPS Excel, MediGuide Enabled guidewire contains a magnetic sensor allowing it to be visualized using the MediGuide system

The Agilis™ PF Introducer System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.

The St. Jude Medical Agilis™ PF Introducer System consisting of an introducer, guidewire, 17Ga Tuohy needle, dilator and obturator is intended to be used to facilitate delivery of SJM devices into the pericardial space for diagnostic and therapeutic purposes. The Agilis™ PF Introducer System consists of the following components: Deflectable introducer, 13 French, Dilator, Guidewire, Obturator, 17Ga Tuohy Needle. The deflectable introducer is fitted with a hemostasis valve to minimize air introduction during introducer insertion and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration and fluid infusion. A handle equipped with a deflection control mechanism deflects the tip up to 90° both clockwise and counterclockwise. The introducer features a radiopaque tip marker to improve fluoroscopic visualization.

The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters intended use is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including implantable left heart leads and delivery tools, and support of fluids where minimizing blood loss is essential. In addition, the outer guide catheters can work with inner catheters as a system.

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The Model 4160 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field. The Model 4161 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field. The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 4051A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

PSA Cable Model Numbers 4160 and 4161 PSA Cable Adapter Model Number 4053A

The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters intended use is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including implantable left heart leads and delivery tools, and support of fluids where minimizing blood loss is essential. In addition, the outer guide catheters can work with inner catheters as a system.

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The St. Jude Medical Mond™ RVOT Stylet is designed to place SJM right ventricular active fixation leads in the right ventricular outflow tract.

The St Jude Medical (SJM) Mond RVOT Stylet is an accessory implant tool, intended for use in the placement of SJM right ventricular active fixation leads. The Mond stylet is configured in a modified "J" shape designed to position the leads in the RVOT. The stylet uses the same materials and similar manufacturing processes as the currently approved J (4090 and 4091) bradycardia stylets and the S-75-X tachycardia stylets.

The CPS DuoTM guidewire and stylet are indicated for: Facilitation of placement of St. Jude Medical left heart leads to target vessel/site.

CPS Duo™ Left Heart Lead Delivery System is a combination of a CPS Duo™ Stylet and a CPS Duo™ Guidewire designed to facilitate the delivery of a SJM lead to the target vessel/site. The CPS Duo™ stylet has a lumen to allow a CPS Duo™ guidewire to pass through it. The CPS Duo™ Guidewire is specially designed to function in concert with the CPS Duo™ Stylet.