FCC ID: LF5P7850N Implantable Neurostimulator

Taiwan Compliance CCALXXXXXXXXXX

. According to "Administrative Regulations on Low Power Radio Waves Radiated Devices" Without permission granted by the NCC, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteristic as well as performance to an approved low power radio-frequency devices. The low power radio-

frequency devices shall not influence aircraft security and interfere legal communications;

If found, the user shall cease operating immediately until no interference is achieved. The said legal communications means radio communications is operated in compliance with the Telecommunications Act. The low power radio-frequency devices must be susceptible with the interference from legal communications or ISM radio wave radiated devices. Communications Regulations The following is a list of communications regulations that apply to the Model P7850N. United States Compliance FCC ID: LF5P7850N This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. Canada Compliance IC: 3408D-P7850N This device contains licence-

exempt transmitter(s)/

receiver(s) that comply with Innovation, Science and Economic Development Canadas licence-exempt RSS(s). Operation is subject to the following two conditions:

(1) This device may not cause interference.

(2) This device must accept any interference, including interference that may cause undesired operation of the device. Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes :

1) Lappareil ne doit pas produire de brouillage;

2) Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. P7850N Communications Regulation Reference Sheet Manufacturer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com Tel. +1-763-505-5000 Authorized Representative in the European Community Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000 Europe/Africa/Middle East Headquarters Medtronic International Trading Srl Route du Molliau 31 Case Postale 84 CH - 1131 Tolochenaz Switzerland www.medtronic.eu Tel. +41-21-802-7000 Asia-Pacific Medtronic International Ltd. 50 Pasir Panjang Road

#04-51 Mapletree Business City Singapore 117384 Singapore Tel. +65-6870-5510 Medtronic 2021 All Rights Reserved M985337A002 Rev A

*M985337A002*

2021-07-01

| Medtronic

(@ medtronic InterStim T Neurostimulator [rer] P7850N yAN conn re euomeston Mm) wivwcoooow SQ yrwvsmno0 4] Yyyy-mim-bd Prason InterStim T Neurostimulator er] P7850N

[5x] wwwooo000w Q vervam.o0 col] Yyyy-Mim-ba SD yrenmnoa:

Is worwooo000W FYR Labels iS) =

meee adi ony iesmspsessasen Yee usa RX Only {ieee ats sat oo Sterile Pack Label meses evo acon a B Shelf Box Label

(ef] P7850N &} Medtronic... REF P7850N lator a IO soem End Label 1 End Label 2 fy Medtronic Qrrranioo Elp78s0n ION 0 0 ica}

Il Ml tL a .

07-20-2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046, USA FCC Agent Authorization Letter Applicant Model Name Medtronic, Inc. P7850N Product Description Implantable Neurostimulator FCC ID LF5P7850N We, the undersigned, hereby authorize Hyundai C-Tech, Inc. dba HCT America Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by Hyundai C-Tech, Inc. dba HCT America Inc. on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). We recognize that we are still responsible for the terms and conditions outlined in the HCT America Client Services Agreement. This authorization is valid until further written notice from the applicant. Sincerely, Guillaume Girard Title Distinguished Regulatory Affairs Advisor Medtronic, Inc. 8200 Coral Sea Street NE Mail Stop MVS11, Mounds View, MN 55112 g.guillaume@medtronic.com Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL:

+1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 1

CFR 47 2.911 (d)(5) Attestation Date: 06-14-2023 FCC ID: LF5P7850N To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA 1. Medtronic, Inc. (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. 2. Medtronic, Inc. (the applicant) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment and is not an affiliate or subsidiary of an entity identified on the Covered List. Sincerely yours, Guillaume Girard Title Distinguished Regulatory Affairs Advisor Medtronic, Inc. 8200 Coral Sea Street NE Mail Stop MVS11, Mounds View, MN 55112 g.guillaume@medtronic.com

CFR 47 2.911 (d)(7) Agent Designation Attestation Date: 06-14-2023 FCC ID: LF5P7850N To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA Medtronic, Inc. (LF5) (the applicant) as required by section 2.911(d)(7), designates the following agent, located in the United States, for purposes of acting as the applicants agent for service of process. The applicant acknowledges that they will maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-

related proceeding involving the equipment. The applicant further acknowledges their responsibility to inform the FCC whenever the agent information changes. U. S. Agent Information:

Contact Person: Guillaume Girard Company name: Medtronic, Inc. Company Address: 8200 Coral Sea Street NE Mail Stop MVS11, Mounds View, MN 55112 Email: g.guillaume@medtronic.com FRN: 0008250839 Sincerely yours, Guillaume Girard Title Distinguished Regulatory Affairs Advisor Medtronic, Inc. 8200 Coral Sea Street NE Mail Stop MVS11, Mounds View, MN 55112

09-07-2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046, USA FCC Confidentiality Request Letter Applicant Model Name FCC ID Medtronic, Inc. P7850N LF5P7850N Pursuant to the provisions of Section 0.457 and 0.459 of the commissions rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Block Diagram Schematics Technical Operation Description Internal Photos (implantable device) The above-mentioned documents contain detailed system and equipment description that are considered propriety information in operation of the equipment. The public disclosure of the above documents might be harmful to our company and would give competitors an unfair advantage in the market. Circuit board and internal components of the P7850N are enclosed in a welded titanium enclosure and implanted in a human body (KDB 726920 3a1). Device model P7850N is implanted into the human body therefore not accessible to the public and can only be access by a health care professional (KDB 726920 3a2). Internal picture is controlled by Medtronic for distribution and mark confidential. NDA template is provided per KDB 72692 if required. In addition to the above mentioned documents, pursuant to Public Notice DA 04-1705 of the Commissions policy, in order to comply with marketing regulations in 47 CFR 2.803 ad the importation rules in 47 CFR 2.1204 while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices. We request that the Commission to grant Short-Term Confidentiality on the following attachments for 180 days after the grant as outlined in Public Notice DA 04-1705. External Photos Test Setup Photos Users Manual Sincerely, Guillaume Girard Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL:

+1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 2 Title Distinguished Regulatory Affairs Advisor Medtronic, Inc. 8200 Coral Sea Street NE Mail Stop MVS11, Mounds View, MN 55112 g.guillaume@medtronic.com Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL:

+1.510.933.8848 || Fax: +1.510.933.8849 Page 2 of 2

07-27-2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046, USA We would like to apply for FCC New Application:

Cover Letter Applicant Model Name(s) Product Type FCC ID Medtronic, Inc. P7850N Implantable Neurostimulator LF5P7850N Please find enclosed our Claim Report, which includes the following:

Confidential Request Letter ID Label and Location Photograph Product External and Internal Photos Agent Authorization Letter Antenna Specification / Data Sheet RF Test Report (if applicable) Block Diagram, Schematics, and Operational Description Users Manual(s) Should you have any questions, please contact us. Sincerely, ______________________ Jenny Huang HCT America, Inc. Jenny.h@hctamerica.com Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL:

+1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 1