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  3. LF5BLEIMPLANT5

LF5BLEIMPLANT5Confirma DR/SR MRI SureScan, Effectra DR/SR MRI SureScan, Refina CSP DR/SR MRI SureScan, Restoria CSP DR/SR MRI SureScan, ReSyncra CSP DR MRI SureScan, HarmoniaBP DR MRI SureScan

Medtronic, Inc.

Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Jul 09, 2026
Application Purpose
Original Equipment
Equipment Note
Confirma DR/SR MRI SureScan, Effectra DR/SR MRI SureScan, Refina CSP DR/SR MRI SureScan, Restoria CSP DR/SR MRI SureScan, ReSyncra CSP DR MRI SureScan, HarmoniaBP DR MRI SureScan
Frequency Range
2402.00000000 - 2480.00000000
Company
Medtronic, Inc.
Country
United States

Documents & Files

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Attestation Statements

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Cover Letter(s)

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ID Label/Location Info

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Attestation Statements

Medtronic, Inc. Cardiac Rhythm Management 710 Medtronic Parkway Fridley, MN-55432 USA Tel: +31 43 356 6540 / +31 6 1320 6854 [email protected] www.medtronic.com Attestation Statement -FCC Date: Mar 30, 2026 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Attestation regarding ‘covered’ equipment and the Covered List FCC ID: LF5BLEIMPLANT5 To whom it may concern, Per 2.911(d)(5)(i), Medtronic, Inc. certifies that the equipment for which authorization is sought i s not “covered” equipment prohibited fro m receivi ng an equipment authorization pursuant to section 2.903 of the FCC rules. Per 2.911(d)(5)(ii), Medtronic, Inc. 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. Per KDB 986446 D01 v03 section B, 2a, Medtronic, Inc. certifies that the equipment for this application does not contain Kaspersky cybersecurity or anti-virus software. Sincerely, ______________________ Christiaan Masson Sr Regulatory Affairs Manager Cardiac Rhythm Management

Attestation Statements

US Agent Attestation Letter TO: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: section 2.911(d)(7) filing To whom it may concern, This letter is to confirm that Guillaume Girard has accepted responsibility to act as the agent for service of process as acknowledged by the applicant, Medtronic inc. Guillaume Girard confirms he is not associated with or part of any TCB or test lab. U.S. Agent: Guillaume Girard Title: Distinguished Regulatory Affairs Advisor Company Name: Medtronic Inc. Address: 8200 Coral Sea Street NE, MN, 55112 Telephone No: 612-991-3108 Email: [email protected] FRN (FCC Registration Number): 0008250839 The applicant accepts and acknowledges the obligation to 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. Signature of Applicant (must be signed by the contact of record in the FCC database for the applicant grantee code): Signature of U.S. Agent (if different from applicant): Name: Guillaume Girard Name: Guillaume Girard Date: March 1 2023 Date: March 1 2023

Cover Letter(s)

Medtronic Medtronic, lnc. 710 Medtronic Parkway Minneapolis, MN-55432, USA www.medtronic.com [email protected] tel +3143 3566540 March 30, 2026 F ederal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbla, Maryland 21046 То whom it may concern. Reference: Applic ation for FCC ID: LF5BLEIMPLANT5, Medtronic Confirma DR MRI SureScan, Effectra DR MRI SureScan, Refina CSP DR MRI SureScan, Restoria CSP DR MRI SureScan, ReSyncra CSP DR MRI SureScan, HarmoniaBP DR MRI SureScan Confirma SR MRI SureScan, Effectra SR MRI SureScan, Refina CSP SR MRI SureScan, Restoria CSP SR MRI SureScan. 1 , the undersigned, as the authorized signatory for Medtronic, lnc. hereby apply to seek original grant for th e Medtronic models listed above. These Implantable Pulse Generator (IPG ) models are single or dual chamber IPG s, which are multi-programmable cardiac devi ces that monitor and regulate the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing and atrial tachyarrhythmia therapies. Wireless data is transmitted through an intentional radiator at 175 kHz and by means of Blue tooth Low Energy. Authorization fo r the BLE radio is sought under FCC Part 15.247. ln case of any additional questions please feel free to contact me. Many thanks in advance. Sincerely, Sr Regulatory Affairs Manager Cardiac Rhythm Management

Cover Letter(s)

Medtronic Medtronic, lnc. 71 0 Medtronic Parkway Minneapolis, MN-55432, US A � vww.medtronic.com March 30 th , 2026 Equipment Authorization Branch Federal Communications Commission ColumЬia, MD 21046 Subject: C onfidentiality Request Letter pertaining to the certification of FCC 1D No: LFSBLEIMPLANT5 Ladies and gentlemen, Medt ronic, lnc. ("Medtronic") requests that the information contained in the items enumerated below pe rtaining to the above-referenced application Ье withheld from puЫic disclosure in accordance with C ommission's 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, Ыосk diagram, and i nternal photographs of а device designed for patients under the саге of а medical professional. A s such, this material is treated as highly confidential business information and information that could co nvey trade secrets pertaining to manufacturing and design techniques. The i nformation for which confidentiality is sought is employed in the design and manufacture of medical device systems that аге offered оп а highly competitive basis. Customers for this equipment have а variety of c ompeting sources of supply from both domestic and foreign suppliers. Disclosure would, in eff ect, give away the fruits of the labors of Medtronic's engineering personnel, who have designed the equipment and the manufactu ring processes. Disclosure would also offer competitors additional u nwarranted insight into the state of product development thereby allowing such competitors ап advantage th at would not Ье availaЫe to Medtronic. The information for which confidential treatment is sought is kept confidential Ьу Medtronic and not m ade availaЫe to third parties except pursuant to arrangements designed to prevent puЫic disclosure. То the knowledge of those preparing this application, the information has not Ьееп disclosed puЬlicly h eretofore. 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 exhiЬits, which аге segregated f rom the non-confidential exhiЬits of the a pplication, а ге the ones for which Medtronic requests Long-Term Confidentiality: lnternal Photos Schematics Block Diagram Theory of Operation / Operational description Parts list / Tune Up lnfo Following the Equipment Authorization Confidentiality Request Procedures as described in КОВ Guidance 726920, lnternal Photos may Ье held Long-Term Confidential under the condition that the circuit board ог internal components аге not accessiЫe to users. Medtronic's lmplantaЫe Pulse Generators, which аге the subject of this future filing, аге not availaЫe to the puЫic. The devices аге Class 3 devices regulated Ьу the FDA and аге availaЫe Ьу prescription o nly Ьу health саге professionals and implanted directly in the patient. As the devices аге sealed hermetically Ьу а titanium сап, opening the device is not possiЫe without destroying it. Therefore, the equipment to which this Long-Т erm Confidentiality request pertains satisfies this criterion. Short-Term Confidentiality The materials set forth in the following exhiЬits, which аге also segregated from the non-confidential exhiЬits of the application, аге the ones for which Medtronic requests Short-Term Confidentiality for а period of 180 days from the date of the grant: - E xternal Photos - User M anuals Respectfully, Christiaan Masson S r. Regulatory Affairs Manager Me dtronic, lnc. Endepolsdomein 5, 6229 GW, Maastricht, the Netherlands Email:christiaan.masson®medtronic.com Phone: +31 43356 6540

Cover Letter(s)

Medtronic Medtronic, Inc. Cardiac Rhythm a nd Heart Failure 7000 Old Central Ave NE Minneapolis, MN 55432 USA www.medtronic.com office 763.526.0652 mobile 612.991.3108 Guillaume Girard Medtronic Inc. Feb 04, 2026 F ederal Communications Commission Laboratory Division 7 435 Oakland Mills Rd C olumbia, MD 21045 Attn: E quipment Authorization and Compliance Branch Chief I, the undersigned, as the authorized signatory fo r Medtronic, Inc., grantee code LF5, hereby authorize Christiaan Masson, Regulatory Affairs Program Manager of Medtronic, Inc., to act on my behalf in all manners relatin g to application for equipment authorization, including signing of all documents relating to such application. Any and all acts carried out by Christiaan Masson of Medtronic, Inc. on our b ehalf shall have the same effects as acts of m y ow n. This authoriz ation shall be sent along with each application when filing with the FCC or TCB for certification of products covered by the above specified FCC ID. This authorization is valid until Feb 4, 2031. l f t here are any q uestions related to this letter, please contact me at Guillaume.girard®medtronic.com (mobile 612.991.3108). Respectfully, Guillaume Girard, Medtronic Inc.

ID Label/Location Info

MEDTRONIC, INC. MINNEAPOLIS, MINNESOTA USA TITLE LABEL IMAGE SPEC BRD1DR1 DR MRI US MEDTRONIC CONFIDENTIAL THIS DOCUMENT IS THE PROPERTY OF MEDTRONIC, INC. AND MUST BE ACCOUNTED FOR. INFORMATION HEREON IS CONFIDENTIAL (INFORMATION SECURITY CLASSIFICATION: SENSITIVE). DO NOT REPRODUCE IT, REVEAL IT TO UNAUTHORIZED PERSONS OR SEND IT OUTSIDE MEDTRONIC WITHOUT PROPER AUTHORIZATION. ImageSpec_Device_I_04 MD0000013934-002 Specification Tabulation MD0000013934-001 Singapore "Manufactured in:" Text Tolochenaz, Switzerland Address Code 005 015 1. This specification is intended to be the final label design output generated from a combination of label parts within the XXassociated PLM EBOM. 2. The label images shown are a representation of printed labels using the EBOM label stock and label software files with the XXlabel system database and manufacturing-provided variable data. 3. Manufacturing printed content: XXa. Printers shall be configured to enable printability of all content. XXb. Printed content shall be positioned on each individual label stock approximately as shown. XXc. Size and position of printed content may vary. XXd. No parts of a letter, whole letter, symbol or graphic shall be blurred, missing or broken which impairs legibility XXXXwhen viewed without magnification. 4. Variable data provided by manufacturing: XXa. Serial Number of the product shall be ten alpha-numeric characters. XXb. Use by Date to populate the indicated format of YYYY-MM-DD. XXc. Date of Manufacture to populate the indicated format of YYYY-MM-DD and be determined from the date of initial battery XXXXconnection. XXd. GTIN and REF number XXe. "Manufactured in:" text per the Specification Tabulation table. 5. The images include representation of the pre-printed label stock. Branding, part number bar codes (2D or other) and XXother pre-printed areas are according to the label stock specification associated to the EBOM item and XXmay differ from the indicated images. 6. The GS1-128 bar code on End Label 1 shall contain: XXa. Encoded bar code data in the following order: XXXXXi. Application Identifier 01 followed by the GTIN XXXXXii. Application Identifier 17 followed by the Use by Date in format YYMMDD XXXXXiii. Application Identifier 21 followed by the Serial Number XXXXXiv. (For versioned GTINS) FNC1 invisible field separator followed by Application Identifier 20 followed by the XXXXXXXtwo-digit GTIN version XXb. Human readable text below the bar code in the following order: XXXXXi. (01) followed by GTIN XXXXXii. (17) followed by Use by Date in format YYMMDD XXXXXiii. (21) followed by Serial Number XXXXXiv. (For versioned GTINS) (20) followed by the two-digit GTIN version 7. Data matrix codes shown on the indicated labels (Shelf Box, Sterile Pack, End Label 1, FYR) XXare provided to facilitate manufacturing. Encoded information is at the discretion of the manufacturing site. 8. FYR shall contain: XXa. Encoded data: XXXXXi. REF Number (REF) encoded in code 39 bar code XXXXXii. Serial Number (SN) encoded in code 39 bar code XXXXXiii. Serial Number (SN) encoded in data matrix code XXb. Human readable text: XXXXXi. REF Number near the REF bar code XXXXXii. Serial Number near the SN bar code XXXXXiii. Serial Number below the SN bar code Template Number MP0000026029_A Document Number MD0000013932 Label Software and Database Information: BRD1DR1MD0000013934AB 1 of 3 SizeDOCUMENT NUMBERREVSHEETMODEL LABEL IMAGE SPEC TEMPLATE: A83320 REV I DRAWING DOES NOT FOLLOW ASME Y14.5 ENGINEERINGDATESCALE N/A TIM WIEGAND 01-Feb-2026 Specification Tabulation Table: 9. FYR UDI shall contain: XXa. Encoded data matrix code in the following order: XXXXXi. Application Identifier 01 followed by the GTIN XXXXXii. Application Identifier 17 followed by the Use by Date in format YYMMDD XXXXXiii. Application Identifier 21 followed by the Serial Number XXb. Human readable text to the right of the data matrix code in the following order: XXXXXi. (01) followed by GTIN XXXXXii. (17) followed by Use by Date in format YYMMDD XXXXXiii. (21) followed by Serial Number 10. The label printed in manufacturing must be at an equal or later model data and XXXtemplate revision as shown on the image. DOCUMENT NUMBER MD0000013934A ImageSpec_Device_I_04 This document is the property of Medtronic and must be accounted for. Information herein is confidential (Information Security Classification: Sensitive). Do not reproduce it, reveal it to unauthorized persons or send it outside Medtronic without proper authorization. TITLE LABEL IMAGE SPEC BRD1DR1 DR MRI US NOTE: IMAGES FOR REFERENCE ONLY NOT TO SCALE LABEL IMAGE SPEC TEMPLATE: A83320 REV I SHEETREV DRAWING DOES NOT FOLLOW ASME Y14.5 Shelf Box Label Sterile Pack Label FYR Labels End Label 1End Label 2 2 of 3 SPEC TAB MD0000013934-001 DOCUMENT NUMBER MD0000013934A ImageSpec_Device_I_04 This document is the property of Medtronic and must be accounted for. Information herein is confidential (Information Security Classification: Sensitive). Do not reproduce it, reveal it to unauthorized persons or send it outside Medtronic without proper authorization. TITLE LABEL IMAGE SPEC BRD1DR1 DR MRI US NOTE: IMAGES FOR REFERENCE ONLY NOT TO SCALE LABEL IMAGE SPEC TEMPLATE: A83320 REV I SHEETREV DRAWING DOES NOT FOLLOW ASME Y14.5 Shelf Box Label Sterile Pack Label FYR Labels End Label 1End Label 2 3 of 3 SPEC TAB MD0000013934-002 MEDTRONIC, INC. MINNEAPOLIS, MINNESOTA USA TITLE LABEL IMAGE SPEC BRD1DR2 DR MRI US MEDTRONIC CONFIDENTIAL THIS DOCUMENT IS THE PROPERTY OF MEDTRONIC, INC. AND MUST BE ACCOUNTED FOR. INFORMATION HEREON IS CONFIDENTIAL (INFORMATION SECURITY CLASSIFICATION: SENSITIVE). DO NOT REPRODUCE IT, REVEAL IT TO UNAUTHORIZED PERSONS OR SEND IT OUTSIDE MEDTRONIC WITHOUT PROPER AUTHORIZATION. ImageSpec_Device_I_04 MD0000013937-002 Specification Tabulation MD0000013937-001 Singapore "Manufactured in:" Text Tolochenaz, Switzerland Address Code 005 015 1. This specification is intended to be the final label design out…

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ID Label/Location Info

Radio Regulatory Compliance Information For devices supporting wireless telemetry Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. FCC compliance information FCC ID: LF5BLEIMPLANT5 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. The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000 Medtronic USA, Inc. Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: +1 800 505 4636 Tachycardia: +1 800 723 4636 Technical manuals www.medtronic.com/manuals *M075733C001* © 2026 Medtronic M075733C001 A 2026-03-25 Printing instructions: doc #163256 Category: Size-selectable no front cover Size: 4.625 x 6 in (117 x 152 mm) 531762-002 M075733C001 A Medtronic Confidential Composed: 2026-03-25 11:19:49 PSN - Size-selectable no front cover 13-SEP-2018

RF Exposure Info

This report must not be used to claim product certification, approval, or endorsement by A2LA, NIST, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. This report is Blockchain Verified. To verify the report’s authenticity, please visit https://www.blockchain-verified.com/ or by clicking the logo to the right. Medtronic, Inc. Model Tested: HarmoniaBP DR MRI SureScan Related Family Models*: Confirma DR MRI SureScan, Effectra DR MRI SureScan Refina CSP DR MRI SureScan, Restoria CSP DR MRI SureScan ReSyncra CSP DR MRI SureScan, HarmoniaBP DR MRI SureScan Confirma SR MRI SureScan, Effectra SR MRI SureScan Refina CSP SR MRI SureScan, Restoria CSP SR MRI SureScan *See Product Description for details FCC 1.1307:2026, FCC 2.1093:2026 Bluetooth Low Energy, Inductive Radio Report: MDTR1212.10 Rev. 01, Issue Date: July 1, 2026 TABLE OF CONTENTS 2023.04.17 Section Page Number Certificate of Evaluation .................................................................................. 3 Revision History .............................................................................................. 4 Facilities .......................................................................................................... 5 Product Description ......................................................................................... 6 Statement of Similarity .................................................................................... 7 Exposure Condition ......................................................................................... 8 Exemption From RF Exposure Evaluation ...................................................... 9 Duty Cycle Calculations .................................................................................. 12 End of Report .................................................................................................. 16 Report No. MDTR1212.10 Rev. 012/16 CERTIFICATE OF EVALUATION 2018-09-14 EXRPT.2025.09.03.0 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing Last Date of Evaluation: February 23, 2026 Medtronic, Inc. EUT: HarmoniaBP DR MRI SureScan RF Exposure Evaluation Standards Specification Method FCC 1.1307:2026 FCC 2.1093:2026 FCC 1.1307:2026 Results Method Clause Description Applied Results Comments (b)(3)(i)(A) Exemption From RF Exposure Evaluation Yes Pass N/A Deviations From Evaluation Standards None Approved By: Donald Facteau, Process Architect Report No. MDTR1212.10 Rev. 013/16 REVISION HISTORY 2025.07.22 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None 01 Updated based upon antenna gain changes 2026-06-25 9-11 Report No. MDTR1212.10 Rev. 014/16 FACILITIES 2025.07.17 Testing was performed at the following location(s) Location Labs (1) Address A2LA (2) ISED (3) BSMI (4) VCCI (5) CAB FDA (6) ☐ California OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 3310.04 2834B SL2-IN-E-1154R A-0029 US0158 TL-55 ☒ Minnesota MN01-11 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612) 638-5136 3310.05 2834E SL2-IN-E-1152R A-0109 US0175 TL-57 ☐ Oregon EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 3310.02 2834D SL2-IN-E-1017 A-0108 US0017 TL-56 ☐ Washington NC01-05 19201 120th Ave NE Bothell, WA 98011 (425) 984-6600 3310.06 2834F SL2-IN-E-1153R A-0110 US0157 TL-67 ☐ Offsite N/A See Product Description N/A N/A N/A N/A N/A N/A See data sheets for specific labs (1) The lab designations denote individual rooms within each location. (OC01, OC02, OC03, etc.) (2) A2LA Certificate No. (3) ISED Company No. (4) BSMI No. (5) VCCI Site Filing No. (6) FDA ASCA No. Report No. MDTR1212.10 Rev. 015/16 PRODUCT DESCRIPTION 2018-07-17 Client and Equipment under Evaluation Information Company Name: Medtronic, Inc. Address: 710 Medtronic Parkway NE City, State, Zip: Minneapolis, MN 55432 Evaluation Requested By: Curt Pies EUT: HarmoniaBP DR MRI SureScan HTN3DR2 Date of Evaluation: February 23, 2026 Information Provided by the Party Requesting the Evaluation Functional Description of the Equipment: The HarmoniaBP system consists of Azure/Astra mechanical architecture with a single chamber and dual chamber MR conditional IPG with wireless communication. The IPG model included in the HarmoniaBP platform technology, spanning the Vitalis device family, is listed in Table 1. SR models are single chamber devices with one (1) IS-1 port in the connector header and DR models are dual chamber devices with two (2) IS-1 ports in the connector header. All models are equivalent from a mechanical perspective with the exception of the connector header and EMA assemblies which account for the different quantities of feedthroughs between SR and DR. All remaining differences between models are related to device features and labeling for different market geographies and have no impact to device/connector test performance. Device models below include two-way short range Inductive telemetry system. Name Confirma DR MRI SureScan Effectra DR …

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Test Report

This report must not be used to claim product certification, approval, or endorsement by A2LA or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. Medtronic, Inc. Model Tested: HarmoniaBP DR MRI SureScan Related Family Models*: Confirma DR MRI SureScan, Effectra DR MRI SureScan Refina CSP DR MRI SureScan, Restoria CSP DR MRI SureScan ReSyncra CSP DR MRI SureScan, HarmoniaBP DR MRI SureScan Confirma SR MRI SureScan, Effectra SR MRI SureScan Refina CSP SR MRI SureScan, Restoria CSP SR MRI SureScan *See Product Description for details FCC 15.247:2026, RSS-247 Issue 4:2025 RSS-Gen Issue 5:2018+A1:2019+A2:2021 Bluetooth Radio Report: MDTR1212.3 Rev. 05, Issue Date: July 2, 2026 This report is Blockchain Verified. To verify the report’s authenticity, please visit https://www.blockchain-verified.com/ or by clicking the logo to the right. TABLE OF CONTENTS 2023.04.17 Section Page Number Certificate of Test ............................................................................................ 3 Revision History .............................................................................................. 5 Facilities .......................................................................................................... 6 Measurement Uncertainty ............................................................................... 7 Test Setup Block Diagrams ............................................................................. 8 Product Description ......................................................................................... 11 Statement of Similarity .................................................................................... 13 Power Settings and Antennas ......................................................................... 15 Configurations ................................................................................................. 16 Modifications ................................................................................................... 17 Duty Cycle ....................................................................................................... 18 DTS Bandwidth (6 dB) .................................................................................... 19 Occupied Bandwidth (99%) ............................................................................. 22 Output Power .................................................................................................. 25 Equivalent Isotropic Radiated Power .............................................................. 28 Power Spectral Density ................................................................................... 30 Band Edge Compliance .................................................................................. 33 Spurious Conducted Emissions ...................................................................... 36 Radiated Spurious Emissions Restricted Band Edge ...................................... 40 Radiated Spurious Emissions Restricted Band Edge – Spot Check ............... 44 Spurious Radiated Emissions ......................................................................... 47 Spurious Radiated Emissions – Spot Check ................................................... 54 End of Report .................................................................................................. 59 Report No. MDTR1212.3 Rev. 052/59 CERTIFICATE OF TEST 2022.04.01 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing. Last Date of Test: May 07, 2026 Medtronic, Inc. EUT: HarmoniaBP DR MRI SureScan Radio Equipment Testing Standards Specification Method FCC 15.247:2026 ANSI C63.10-2020 + Cor.1-2023 RSS-247 Issue 4:2025 ANSI C63.10-2020 + Cor.1-2023+C63.10a-2024 + Errata to C63.10a-2024 RSS-Gen Issue 5:2018+A1:2019+A2:2021 Guidance FCC KDB 558074 v05r02:2019 Notice 2021 - CEB0001 Results Test Description Result FCC Section(s) RSS Section(s) ANSI C63.10 Section(s) Comments Powerline Conducted Emissions N/A 15.207 RSS-Gen 8.8 6.2 Not required for a battery powered EUT. Duty Cycle N/A KDB 558074 -6.0 RSS-Gen 3.2 11.6 See data. DTS Bandwidth (6 dB) Pass 15.247(a)(2), KDB 558074 -8.2 RSS-247 6.3.1(a) 11.8.2 Occupied Bandwidth (99%) N/A KDB 558074 -2.1 RSS-Gen 6.7 6.9.3 See data. Output Power Pass 15.247(b)(3), KDB 558074 -8.3.1 RSS-247 6.3.2, RSS-Gen 6.12 11.9.1.1 Equivalent Isotropic Radiated Power Pass 15.247(b)(3), KDB 558074 -8.3.1 RSS-247 6.3.2, RSS-Gen 6.12 11.9.1.1 Power Spectral Density Pass 15.247(e), KDB 558074 -8.4 RSS-247 6.3.1(b) 11.10.2 Band Edge Compliance Pass 15.247(d), KDB 558074 -8.5 RSS-247 6.6 11.11 Spurious Conducted Emissions Pass 15.247(d), KDB 558074 -8.5 RSS-247 6.6 11.11 Radiated Band Edge Emissions Pass 15.247(d), KDB 558074 - 8.6, 8.7 RSS-247 6.6, RSS- Gen 6.13, 8.10 11.12.1, 11.13.2, 6.6 Spurious Radiated Emissions Pass 15.247(d), KDB 558074 - 8.6, 8.7 RSS-247 6.6, RSS- Gen 6.13, 8.10 11.12.1, 11.13.2, 6.4, 6.5, 6.6 Report No. MD…

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Test Report

This report must not be used to claim product certification, approval, or endorsement by A2LA or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. Medtronic, Inc. Confirma SR MRI SureScan Model BRD1SR1 HarmoniaBP DR MRI SureScan Model HTN3DR2 Active 3D Antenna Pattern Measurements Report: MDTR1264.0 Rev. 0, Issue Date: June 24, 2026 Approved by: Trevor Buls, Principal EMC Test Engineer Signed for and on behalf of Element This report is Blockchain Verified. To verify the report’s authenticity, please visit https://www.blockchain-verified.com/ or by clicking the logo to the right. TABLE OF CONTENTS 2023.04.17 Section Page Number Revision History .............................................................................................. 3 Facilities .......................................................................................................... 4 Product Description ......................................................................................... 5 Modifications ................................................................................................... 7 OTA Measurement Summary .......................................................................... 8 Active 3D Antenna Pattern Measurements ..................................................... 10 End of Report .................................................................................................. 29 Report No. MDTR12642/29 REVISION HISTORY 2025.07.22 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None Report No. MDTR12643/29 FACILITIES 2025.07.17 Testing was performed at the following location(s) Location Labs (1) Address A2LA (2) ISED (3) BSMI (4) VCCI (5) CAB FDA (6) ☐ California OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 3310.04 2834B SL2-IN-E-1154R A-0029 US0158 TL-55 ☒ Minnesota MN01-11 9349 W Broadway Ave. Brooklyn Park, MN 55445 (6…

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Contact Information

Applicant

Guillaume Girard(Sr. RF Regulatory Program Manager)
[email protected]Fax: 651-367-0603

Test Firm

Element Materials Technology Minneapolis -BrooklynElliot Martinez
[email protected]

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz1.00 mW
Confidentiality
Long Term
Grant Notes
Power listed is conducted.

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DTS - Digital Transmission System
LF5BLEIMPLANT4

Cobalt XT VR MRI SureScan, Cobalt VR MRI, Crome VR MRI, Cobalt XT DR MRI, Cobalt DR MRI, Crome DR MRI, Cobalt XT HF Quad CRT-D MRI, Cobalt XT HF CRT-D MRI, Cobalt HF Quad CRT-D MRI, Cobalt HF CRT-D MRI, Crome HF Quad CRT-D MRI, Crome HF CRT-D MRI

Apr 01, 2020

Equipment Class

DTS - Digital Transmission System