Updated Confidentiality Statement

1506-EX-ST-2016 Text Documents

Medtronic MiniMed Inc.

2016-10-19ELS_183412

Medtronic Requestfor Confidentiality STA File Number: 1506—EX—ST—2016 STA Confirmation Number: EL253955 Attention: Application Examiner Dear Sir or Madam, In accordance with 47 CFR §0.459 (b), Medtronic Diabetes requests that information submitted in the application for a Special Temporary Authority be held confidential and not be made available for public inspection for the following reasons: (1) Identification of the specific information for which confidential treatment is sought: Medtronic requests the device specific information disclosed in EXHIBIT A be kept confidential. (2) Identification of the Commission proceeding in which the information was submitted or a description of the circumstances giving rise to the submission: Medtronic‘s application for a Special Temporary Authority, STA File Number: 1506—EX—ST—2016 (3) Explanation of the degree to which the information is commercial or financial, or contains a trade secret or is privileged: The request for confidentiality pertains to information that addresses both commercial and trade secret concerns. Explanation of the degree to which the information concerns a service that is subject to competition: The information disclosed in EXHIBIT A concerns the development of devices for the medical electronics industry. The medical electronics industry is highly competitive, and developing products for this industry involves a substantial degree of financial investment and financial risk. (5) Explanation of how the disclosure of the information could result insubstantial competitive harm: Disclosure of the information in the EXHIBIT A will inform our competitors of technology we‘re employing to address a competitive market. (6) Identification of any measures taken by the submitting party to prevent unauthorized disclosure: Medtronic maintains Non—Disclosure Agreements (NDA‘s) with participants in the proposed research project, and vendors supplying equipment related to the research project. (7) Identification of whether the information is available to the public and the extent of any previous disclosure of the information to third parties: As of this date, the information in been disclosed in EXHIBIT A has not been made available to the public by Medtronic. All other disclosures to third parties are protected by NDA‘s. (8) Justification of the period during which the submitting party asserts that the material should not be available for public disclosure: Medtronic requests the material described in application be withheld for public disclosure for a period of 3 years. This period will provide Medtronic suitable time to develop the product for sale in the market.

(9) Any other information that the party seeking confidential treatment believes may be useful in assessing whether its request for confidentiality should be granted: None. List of Exhibits: EXHIBIT A: Experimental License Narrative Statement. File Number 1506—EX—ST—2016 If you have questions or need further information, please contact the undersigned. Sincerely, (\Wokn~ Robert Vitti Sr. Manager, System Verification Medtronic Diabetes 18000 Devonshire Street Northridge, CA 91325—1219 Tel: 818—576—4069 E—mail: bob.vitti@medtronic.com


Document Created: 2016-10-19 08:56:51
Document Modified: 2016-10-19 08:56:51
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