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The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

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The PT2TM Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The PT2TM Guide Wires are not intended for use in the cerebral vasculature. The AddWireTM Extension Wire creates an extended guide wire that can be used to exchange out a therapeutic device without removing the original guide wire from the anatomy. When the exchange is complete, the Extension Wire can be detached and the original guide wire can be used in a conventional manner.

**Guide Wire:** The PT2TM Guide Wires with ICE® hydrophilic coating are steerable, polymer-tipped guide wires. The PT2TM is available in a nominal diameter of 0.014 inches, two rail support models, Light Support and Moderate Support, and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The distal two centimeters of all models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip. The 185-centimeter version of the PT2TM is designed with a proximal extension section. This proximal extension section allows connection to the AddWireTM Extension Wire or the similarly designed TrooperTM/PatriotTM Extension Wire. The PT2TM corewire consists of a PTFE coated SS corewire segment coupled to a tapered Nitinol corewire segment. The PT2TM coupler is a stainless steel material. The distal most end of the PT2TM corewire is a SS ribbon. The distal tapered Nitinol corewire segment of the PT2TM is coated with an adhesive pre-coat. The pre-coated corewire is then jacketed with a Tungsten loaded polyurethane sleeve. The entire polymer sleeve of the PT2TM Guide Wire is coated with ICE® Hydrophilic coating. **Extension Wire:** The AddWireTM Extension Wire is a PTFE coated SS wire with a connector at the distal end that connects to the proximal end of BSC extendable guide wires. The nominal length is 145 cm and the nominal diameter is 0.014 inches. The AddWireTM Extension Wire is similar in design and materials to the LRM Extension Wire that is currently marketed by BSC as the TrooperTM/PatriotTM Extension Wire.

The Express™ Biliary LD Premounted Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

The 27 mm Express Biliary LD Premounted Stent System will be identical to the currently marketed Express Biliary LD Premounted Stent Systems (K021630). The Express Biliary LD Stent is a balloon expandable metallic stent intended to maintain patency of biliary strictures produced by malignant neoplasms. The stent will be available in a variety of sizes to address clinician needs. The Express Biliary LD Stent is made from 316L surgical grade stainless steel tubing. The seamless tubing is initially extruded to a cylindrical shape, and is then drawn down in a series of steps to the final tubing dimension. The stent is formed by laser cutting the pattern from the tube, after which it is cleaned and electropolished to obtain smooth rounded struts. The geometry is a continuous pattern consisting of large and small sinusoidal bands connected by axial struts. The deployed stent provides radial strength while conforming to the natural curvature of the anatomy. The stent provides a ghost like image using conventional radiographic imaging equipment. The currently marketed Express Biliary LD Premounted Stent System is offered with stent diameters of 6 - 10 mm, in one mm increments. The 6 - 8 mm diameter stents has lengths of 17 mm, 37 mm, and 57 mm. The 27 mm length is proposed for these stent diameters and is the subject of this submission. These are considered to be the Small Lumen (SL) models. The 9 mm and 10 mm diameter stents have lengths of 25 mm. 37 mm, and 57 mm. These are considered to be the Large Lumen (LL) models. The balloon delivery catheter for the 27 mm Express Biliary LD Premounted Stent System will be identical to the one utilized on the currently marketed Express Biliary LD Premounted Stent Systems (K021630). The Balloon Delivery Catheter is an over-the-wire catheter offered in a two lumen catheter shaft design. One lumen is used to pass the catheter over a guide wire. The proposed device is designed to be placed over guide wires which have outer diameters of 0.035" or smaller. This lumen can also be used for infusion of contrast medium. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the stenting procedure. The guide wire lumen and the balloon lumen terminate at the proximal end of the catheter by means of a bifurcated hub with luer lock fittings.

The Ultra-soft SV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Ultra-soft SV Percutaneous Transluminal Angioplasty (PTA) catheter is a Monorail™ catheter with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The distal segment of the balloon catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon. The wire lumen permits the use of guidewires (≤0.018 in / 0,46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated.

The WALLGRAFT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Wallgraft Endoprosthesis (stent graft) consists of a metallic stent comprised of biomedical superalloy monofilament wire with a radiopaque core, braided in a tubular mesh configuration. A platinum nickel micro-cable is incorporated into the stent to enhance radiopacity of the device. A graft material comprised of braided polyester varn (PET) is adhesively bonded to the outside of the metallic stent. This design configuration results in a stent graft that is flexible, compliant, and self-expanding with the barrier characteristics of a tubular graft. The Unistep Plus Delivery System consists of a coaxial tube system. The exterior tube serves to constrain the stent graft over the interior tube until retracted during deployment. The coaxial tubes have the capability of re-constraining the stent graft after partial deployment. A holding sleeve and stent cup, attached to the interior tube, aid in the re-constraining process. Radiopaque marker bands situated adjacent to the proximal and distal ends of the stent graft facilitate imaging during deployment. A radiopaque marker band located on the exterior tube and a limit marker band on the interior tube function as deployment limit markers. Re-constrainment is possible up to the point where the exterior tube marker band is proximally retracted to the location of the interior tube limit marker. The interior tube of the coaxial system contains a central lumen which will accommodate a 0.035" guide wire. The delivery system will be available in a single working length of 90 cm.

The Biliary Wallstent® Endoprosthesis with Monorail Delivery System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

The Boston Scientific Medi-Tech Transhepatic Biliary Wallstent Endoprosthesis with Monorail Delivery System consists of the following components: - Biliary Stent - Monorail Delivery System The Biliary Wallstent covered in this submission is a self-expanding endoprosthesis constructed of biomedical DFT (drawn filled tubing) monofilament wires, braided in a tubular mesh configuration. It is designed to self-expand to a specified diameter following deployment into the stricture. The Biliary Wallstent is provided pre-mounted on a monorail type delivery system. The stent will be available in unconstrained diameters of 6.0, 8.0 and 10.0 mm. The three stent diameters will be available in the following lengths. | Stent Diameter | Stent Unconstrained Length | |----------------|----------------------------| | 6.0 mm | 22 mm | | 8.0 mm | 21 mm, 29 mm and 36 mm | | 10.0 mm | 24 mm, 31 mm and 37 mm | The monorail delivery instrument consists of two coaxially arranged shafts: an inner shaft made of stainless steel proximally and thermoplast distally, and an outer sheath made of thermoplast. The central lumen within the inner shaft continues to the tip and accepts a 0.014" guide wire through the distal tip that exits the inner through two guide wire holes (inner and outer exit holes). The stent is pre-loaded on the stent carrier located on the distal segment of the inner shaft. Two radiopaque markers on the inner shaft and one radiopaque marker on the retractable outer shaft are used to facilitate stent placement. The proximal end of the stent is firmly held on the inner shaft with a stent holder, which enables a partially deployed stent to be recaptured and repositioned, if desired. A black release marker on the proximal stainless steel shaft identifies the maximum deployment allowable for recapture of the stent. The distal end of the outer sheath covers the stent and is retracted to allow for stent deployment. The space between the coaxial inner shaft and the outer sheath is accessed through the T-connector. All catheter models have the same overall length.

The NIROYAL® Biliary Premounted Stent System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

The NIROYAL® Biliary Premounted Stent System (NIROYAL® Biliary System) is a stent system consisting of a 0.018" balloon delivery catheter and a gold plated stainless steel stent. The modified NIROYAL® Biliary System is the same as the NIROYAL® Biliary System cleared under K003929, with the exception of the delivery balloon size for the 7 mm x 14 mm stent. The 7 mm x 14 mm stent will be mounted on a 20 mm balloon, instead of a 15 mm balloon as described in K003929.