summaryofsafetyandeffectivenessdata.docVIP

4. Summary of Safety and Effectiveness Data Attached is a detailed Summary of Safety and Effectiveness for the VNS Therapy System. The document was prepared in accordance with the Pre-Market Approval (PMA) Manual (1998). A CD ROM containing a soft copy of this document (formatted in Microsoft Word) was submitted with this PMA Supplement and is labeled VNS Therapy System for depression - Summary of Safety and Effectiveness. Summary of Safety and Effectiveness GENERAL INFORMATION Device Generic Name: Stimulator, Vagus Nerve Device Trade Names: VNS Therapy? System VNS Therapy? Pulse Model 102 Generator VNS Therapy? Pulse Duo Model 102R Generator VNS Therapy? Programming Wand Model 201 VNS Therapy? Magnet Model 220 VNS Therapy? Software Model 250 VNS Therapy? Lead Model 302 VNS Therapy? Tunneler Model 402 VNS Therapy? Accessory Pack Model 502 Applicants Name and Address: Cyberonics, Inc. 100 Cyberonics Boulevard Cyberonics Building Houston, Texas 77058 USA PMA Number: P970003 Date of Panel Recommendation: ___________, 2004 Date of Notice of Approval to the Applicant: ___________, 2004 Indications for Use The VNS Therapy System is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients over the age of 18 who are experiencing a major depressive episode that has not had an adequate response to two or more adequate antidepressant treatments. CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS A. Contraindications The VNS Therapy System cannot be used in patients after a bilateral or left cervical vagotomy. Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (hereafter referred to as diathermy) on patients implanted with a VNS Therapy System. Diagnostic ultrasound is not included in this contraindication. Energy delivered by diathermy may be concentrated into or reflected by implanted products such as the VNS Therapy System. This concentration or reflection of energy may