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CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Limitations: The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR §801.109.Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months when used in the treatment of benign biliary strictures secondary to chronic pancreatitis. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV has not been established in the treatment of benign biliary anastomotic strictures in liver transplant patients and benign biliary post abdominal surgery strictures. Testing of overlapped stents has not been conducted. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS

All trademarks are the property of their respective owners. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product.

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