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The Interlock™ Fibered IDC™ Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.

The Interlock Fibered IDC Occlusion System includes a coil (manufactured from platinum-tungsten alloy) that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock Fibered IDC Occlusion Coil is designed to be delivered under fluoroscopy with a 0.0 21 in (0.53 mm) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with one or two radiopaque (RO) tip markers. The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.

The proposed Pelvic Floor Repair System is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The proposed device is a sterile, single use kit, consisting of two synthetic mesh assemblies and a needle holder. Each mesh assembly consists of a polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the Capio™ Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement. The proposed mesh configurations were designed for performing vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs.

The proposed Boston Scientific power injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The proposed PICC is designed for intravenous therapy and for use with power injectors at settings of 300 psi for the administration of contrast media for imaging studies (including, but not limited to, CT scans, MRIs). The proposed PICC is an open ended, non-valved catheter with proximally located luer lock hub(s), extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL); with a reverse tapered shaft to aid in staunching bleeding at the insertion site; and usable length of 45 cm lengths for the 4 Fr SL, 5 Fr DL lengths and 55 cm lengths for the 4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL. The radiopaque catheter is marked with depth indicators every 1 cm along its length and with a "0" indicator to serve as a reference during catheter insertion and for user convenience in catheter sizing. The lumens are differentiated by proximally located colored clamps and hubs that indicate lumen size. Maximum power injection flow rates are indicated on the clamp(s). As is the predicate device, the proposed BSC PICC will be offered in convenience kits with other legally marketed products.

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

The Express Biliary SD Premounted Stent System is available in the models indicated in Table 4.3. A brief description of the device components follows. The Express Biliary SD 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 SD stent is made from 316L surgical grade stainless steel. The stent geometry is a laser-cut pattern consisting of large and small sinusoidal bands connected by axial struts. Additional struts are provided to reinforce the three connector rows of the proximal stent end, resulting in additional scaffolding designed to reduce tumor in-growth at the proximal stent end. The delivery system for the Express Biliary SD Premounted Stent System consists of a Monorail™ catheter with a stent crimped on 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 stricture to be dilated.