FCC ID: 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

1. The label images shown are a representation of printed labels using the EBOM label stock and label software files XXwith the label system database and manufacturing-provided data. 2. 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. Printed content shall be indelible. XXe. No parts of a letter, whole letter, symbol or graphic shall be blurred, missing or broken which impairs legibility XXXXwhen viewed without magnification. 3. Data provided by manufacturing:

XXa. Serial Number 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. PIN number shall be ten alpha-numeric characters. XXe. REF number XXf. "Manufactured in:" text per the Specification Tabulation table. 4. 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 (also known as UPN) 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 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 5. Data matrix codes shown on the indicated labels (Shelf Box, Sterile Pack, End Label 1, End Label 3, FYR [upper left corner]) XXare provided to facilitate manufacturing. Encoded information is at the discretion of the manufacturing site. 6. The FYR Labels shall contain:

XXa. Encoded data:

XXXXXi. REF Number for the REF Code 39 bar code XXXXXii. Serial Number for the SN Code 39 bar code XXXXXiii. Serial Number for the SN data matrix code XXb. Human readable text:

XXXXXi. REF Number above the REF Code 39 bar code XXXXXii. Serial Number above the SN Code 39 bar code XXXXXiii. Serial Number below the SN data matrix code 7. The label printed in manufacturing may be at an equal or later model data and template revision as shown on each label. Specification Tabulation

"Manufactured in:" Text A94231-001 Tolochenaz, Switzerland DeviceImageSpecEnd3_05

LABEL IMAGE SPEC-COBALT XT HF QUAD CRTD MRI DTPA2QQ OUS MKT LABEL IMAGE SPEC TEMPLATE: A83320 REV E

12-Sep-2019

DTPA2QQ

B

TIM WIEGAND

A94231

A 1 of 2

Shelf Box Label Sterile Pack Label FYR Labels End Label 1 End Label 2 End Label 3

SPEC TAB A94231-001 NOTE: IMAGES NOT TO SCALE LABEL IMAGE SPEC TEMPLATE: A83320 REV E PART NUMBER A94231 REV SHEET A 2 of 2

LABEL IMAGE SPEC-COBALT XT HF QUAD CRTD MRI DTPA2QQ OUS MKT DeviceImageSpecEnd3_05

Medtronic Medtronic, Inc. Cardiac 7000 Old Central Minneapolis, MN 55432 Ave NE Rhythm and Heart Failure USA www.medtronic.com office 763.526.0652 mobile 612.99 1.3108 Guillaume Girard Medtronic Inc. August 27, 2019 Communications Commission Federal Laboratory 7 435 Oakland Mills Rd Columbia, MD 21045 Division Attn: Equipment Authorization and Compliance Branch Chief I, the undersigned, as authorize Christiaan on my behalf in all manners relating to app signing of all documents relating to such app the authorized signato Masson, Regulatory Aff ry for Medtronic, I airs Program Man nc., grantee code LF5, hereb y ager of Medtronic, Inc., to act lication for equipment authorization, inc lication. luding Any and all acts c the same effects as acts of my own arried out by Christiaan Masson of

. Medtronic, I nc. on our behalf shall have This authorization shall be sent a for certification of products cov valid until August 1, 2023. long with each applic ered by the above s ation when filing with t he FCC or TCB pecified FCC ID. This authorization is lf there are any Guillaume.girardmedtronic.com (mo er, please c

.991.3108). questions related to this lett ontact me at bile 612 Respectfully, Guillaume Girard, Medtronic Inc.

US Agent Attestation Letter Federal Communications Commission TO:

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:

710 Medtronic Parkway, MN, 55432 Telephone No: 612-991-3108 Email: Guillaume.girard@medtronic.com 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

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6393681.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case Medtronic, Inc. Cardiac Rhythm Management 710 Medtronic Parkway Fridley, MN-55432 USA Tel: +31 43 356 6540 / +31 6 1320 6854 christiaan.masson@medtronic.com www.medtronic.com Attestation Statement -FCC Date: Feb 27, 2023 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: LF5BLEIMPLANT4 To whom it may concern, Per 2.911(d)(5)(i), Medtronic, Inc. 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. 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. Sincerely, ______________________ Christiaan Masson Regulatory Affairs Manager Cardiac Rhythm Management

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6393679.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case February 27, 2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 To whom it may concern. Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN-55432, USA www.medtronic.com Christiaan.masson@medtronic.com tel +31 43 3566540 Reference: Class II Permissive Change Request for FCC ID LF5BLEIMPLANT4, Medtronic Cobalt/Crome family of implantable devices:

Cobalt XT VR MRI SureScan Crome VR MRI SureScan

- Cobalt VR MRI SureScan

- Cobalt XT DR MRI SureScan Cobalt DR MRI SureScan Cobalt XT HF Quad CRT-D MRI SureScan Cobalt HF Quad CRT-D MRI SureScan

- Crome DR MRI SureScan

- Cobalt XT HF CRT-D MRI SureScan

- Cobalt HF CRT-D MRI SureScan, Crome HF Quad CRT-D MRI SureScan

- Crome HF CRT-D MRI SureScan I, the undersigned, as the authorized signatory for Medtronic, Inc. hereby apply for a Class II Permissive Change authorization for FCC ID LF5BLEIMPLANT4 to authorize a minor change. The Medtronic Cobalt and Crome models include inductive telemetry at 175 kHz and Bluetooth Low Energy at 2402-2480 MHz and an FCC grant was obtained for the BLE telemetry. Medtronic recently identified an issue with the Cobalt and Crome hardware that has the potential to exhibit a low-level leakage current through the BLE antenna to ground. Adding a DC blocking capacitor in series with the antenna will eliminate this potential current pathway to ground. The change is included in the radio schematic document. C401 currently exists as a discrete component but will be moved between the BLE antenna and its matching network to act as a DC blocking capacitor. The functionality previously associated with C401 will now be associated with C403; C403 will be an integrated component realized by the topology of the printed circuit board layers. Testing was performed to FCC 15.247 which is included in this Class II Permissive Change application, together with the updated schematics, and applicable BOM and internal pictures. In case of any additional questions please feel free to contact me. Many thanks in advance. Sincerely, ___________________________ Christiaan Masson Regulatory Affairs Manager Cardiac Rhythm Management

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6393682.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case Medtronic, Inc. Cardiac Rhythm Management 710 Medtronic Parkway Fridley, MN-55432 USA Tel: +31 43 356 6540 / +31 6 1320 6854 christiaan.masson@medtronic.com www.medtronic.com February 27th, 2023 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Subject: Confidentiality Request Letter pertaining to the Class II Permissive Change Request of FCC ID No: LF5BLEIMPLANT4 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, and internal photographs of devices 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 Schematics Theory of Operation / Operational description Parts list Following the Equipment Authorization Confidentiality Request Procedures as described in KDB Guidance 726920 D01, Internal Photos may be held Long-Term Confidential under the condition that the circuit board or internal components are not accessible to users. Medtronics implantable devices, which are the subject of this 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. As the devices are sealed by a titanium enclosure, opening the device is not possible. Therefore, the equipment to which this Long-Term Confidentiality request pertains satisfies this criterion. Sincerely, ______________________ Christiaan Masson Regulatory Affairs Manager Cardiac Rhythm Management