Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN-55432, USA www.medtronic.com ID No:
May 9, 2019 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Subject: Confidentiality Request Letter pertaining to the certification of FCC LF5BLEIMPLANT3 Ladies and gentlemen, Medtronic, Inc. (Medtronic) requests that the information contained in the items enumerated below pertaining to the above-referenced application be withheld from public disclosure in accordance with Commissions Rules, 47 C.F.R. 0.457(d) and 0.459, following grant of the application. The confidential information is embodied in circuit diagrams, detailed explanations, parts lists, block diagram, and internal photographs of a device designed for patients under the care of a medical professional. As such, this material is treated as highly confidential business information and information that could convey trade secrets pertaining to manufacturing and design techniques. The information for which confidentiality is sought is employed in the design and manufacture of medical device systems that are offered on a highly competitive basis. Customers for this equipment have a variety of competing sources of supply from both domestic and foreign suppliers. Disclosure would, in effect, give away the fruits of the labors of Medtronics engineering personnel, who have designed the equipment and the manufacturing processes. Disclosure would also offer competitors additional unwarranted insight into the state of product development thereby allowing such competitors an advantage that would not be available to Medtronic. The information for which confidential treatment is sought is kept confidential by Medtronic and not made available to third parties except pursuant to arrangements designed to prevent public disclosure. To the knowledge of those preparing this application, the information has not been disclosed publicly heretofore. The protection sought is narrowly drawn and pertains to certain specific implementations of the technology incorporated into the device for which certification is sought. Long-Term Confidentiality The materials set forth in the following exhibits, which are segregated from the non-confidential exhibits of the application, are the ones for which Medtronic requests Long-Term Confidentiality:
Internal Photos
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- Schematics
- Block Diagram
- Theory of Operation / Operational description Following the Equipment Authorization Confidentiality Request Procedures as described in KDB Guidance 726920 D01 of April 8th 2016, Internal Photos may be held Long-Term Confidential under the condition that the circuit board or internal components are not accessible to users. Medtronics LINQ II Insertable Cardiac Monitor, which is the subject of this future filing, are not available to the public. The devices are Class 3 devices regulated by the FDA and are available by prescription only by health care professionals and implanted directly in the patient. As the devices are sealed hermetically by a titanium can, opening the device is not possible without destroying it. Therefore, the equipment to which this Long-Term Confidentiality request pertains satisfies this criterion. Short-Term Confidentiality The materials set forth in the following exhibits, which are also segregated from the non-confidential exhibits of the application, are the ones for which Medtronic requests Short-Term Confidentiality for a period of 180 days from the date of the grant:
- External Photos
- Test Setup Photos
- User Manuals Respectfully, ____________________________ Christiaan Masson Regulatory Affairs Program Manager Medtronic, Inc. Endepolsdomein 5, 6229 GW, Maastricht, the Netherlands Email:christiaan.masson@medtronic.com Phone: +31 43 356 6540