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The Zimmer Ambulatory Pump Kit, Pain Management System is indicated for patients requiring continuous infusion of medications directly into an intraoperative, subcutaneous or epidural site for postoperative pain management. The system is convenient for use by ambulatory patients. It is the responsibility of the user to assure that the medication is prepared and administered in accordance with the drug manufacturer's package insert.

The Zimmer Ambulatory Pump Pain Management System is a convenience kit that is comprised of legally marketed devices. The devices are purchased non-sterile and subsequently packaged in tray kits by Zimmer. Once packaged, the kit will be sent to a contract sterilizer for irradiation sterilization. The proposed convenience kit does not change the intended use of the legally marketed devices which comprise the kit. The Zimmer Ambulatory Pump Pain Management System (kit) does not raise any new safety and effectiveness concerns when compared to the similar legally marketed devices. The Zimmer Ambulatory Pump Pain Management System should therefore be considered substantially equivalent to the existing predicate devices.