THS-SX-C

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<h2>Indications, Safety, and Warnings</h2> <p><b>Note: Safety information provided is for the United States. Refer to your region’s instructions for use for specific details.</b></p> <p>This therapy is not for everyone. Please consult your physician. A prescription is required. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions. </p> <h3>Important information</h3> <p>Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.</p> <h3>Indications for use </h3> <p>The TurboHawk™ peripheral plaque excision system is intended for use in the atherectomy of the peripheral vasculature. The TurboHawk™ catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.</p> <p>The TurboHawk™ catheter is indicated for use in conjunction with the SpiderFX™ embolic protection device in the treatment of severely calcified lesions (LX-C only).</p> <p><b>Caution:</b> Federal law (United States) restricts this product for sale by or on the order of a physician.</p> <p>FTSOP113326-66 Rev. 1C</p>

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