UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported): September 15, 2004

CYBERONICS, INC.

(Exact name of registrant as specified in its charter)

Delaware
(State or other
jurisdiction of
incorporation) 0-19806
(Commission
file number) 76-0236465
(IRS Employer
Identification No.)

Cyberonics Building
100 Cyberonics Boulevard
Houston, Texas 77058
(Address of principal executive offices) (Zip code)

(281) 228-7200
Registrant’s telephone number, including area code:

TABLE OF CONTENTS

Press Release dated September 15, 2004

Item 8.01 Other Events

     On September 15, 2004, Cyberonics, Inc. (“Company”) issued a press release announcing that it has submitted a Treatment IDE, at the suggestion of FDA’s Center for Devices and Radiological Health (CDRH), to make VNS Therapy available to patients with life-threatening treatment-resistant depression (TRD) in a multi-center, open-label, uncontrolled, longitudinal trial, while the FDA and Company continue to discuss the Company’s pending Expedited Review PMA-Supplement requesting approval to market VNS Therapy for chronic or recurrent treatment-resistant depression. The Company also conducted a conference call during which it discussed the press release. A copy of the press release is attached as an exhibit.

     In accordance with General Instruction B.2. of Form 8-K, the Press Release attached hereto as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits

     (c) Exhibits

99.1 Press Release of Cyberonics, Inc. dated as of September 15, 2004.

SIGNATURE

     Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

CYBERONICS, INC.
 

/s/ David S. Wise  

David S. Wise 

Vice President, General Counsel and Secretary 

Date: September 16, 2004

EXHIBIT LIST

Exhibit
Number	Description
99.1	Press Release of Cyberonics, Inc. dated as of September 15, 2004.