COVER LETTER

24.03.2024

FROM

NURA Medical Device inc.,

360 Huntington Ave,

Boston, MA 02115,

United States.

TO

Bureau of Licensing Services

Medical Devices Directorate

Health Canada

11 Holland Avenue

Address Locator: 3002A

Ottawa, Ontario

K1A 0K9.

Subject: Application for Medical Device Establishment License for Import of NURA-LINK™ Leadless
Pacemaker System

Dear Sir/Madam,

I am writing to apply for a Medical Device Establishment License (MDEL) for the import of the NURA-
LINK™ Leadless Pacemaker System into Canada. Enclosed with this letter are all the necessary
documentation and a detailed checklist to facilitate the processing of our application. Additionally, we
have submitted the required Medical Device License (MDL) application form, MDL application fee form,
Premarket Submission Documents, and supporting SOPs.

The NURA-LINK™ Leadless Pacemaker System represents a groundbreaking advancement in addressing

adult bradycardia and conduction abnormalities. Offering a single-chamber device with innovative
features, including the elimination of leads and pockets, conditional MRI compatibility, and enhanced
patient comfort, this system holds significant potential to revolutionize patient care and improve quality
of life.

Please note that this application includes information on the NURA-LINK™ Leadless Pacemaker System,
including additional details on device specifications, distribution records, storage procedures, and risk
management assessments. These updates reflect our ongoing commitment to regulatory compliance and
continuous improvement.

The following documents are included as part of our application:

• Completed Application Form for Medical Device Establishment License.

• Completed Application Form for Medical Device License
• Completed Fee Form for Medical Device License
• Detailed Description of the NURA-LINK™ Leadless Pacemaker System.
• Distribution Records for the NURA-LINK™ Leadless Pacemaker System.
• Documentation of Storage Procedures.
• Complaint Handling Procedures.
• Delivery Protocols.
• Recall Management Plan.
• Installation Guidelines.
• Incident Reporting Procedures.
• Corrective Action Plan.
• Risk Management Assessment for Serious Risk of Injury to Human Health.

We are available to provide any further information or clarification necessary to expedite the processing
of our application. Thank you for considering our request.

Yours faithfully,

NURA Medical Device inc.,

360 Huntington Ave,

Boston, MA 02115,

United States.