# 2025-11028: FDA Patent Review for a Pacemaker With No Leads

2025-11028, Determination of Regulatory Review Period for Purposes of Patent Extension; [AVEIR VR LEADLESS SYSTEM], is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16, effective Anyone with knowledge that any of the dates as published may submit comments and ask for a redetermination by August 15, 2025. Any interested person may petition FDA for a determination regarding whether the applicant acted with due diligence during the regulatory review period by December 15, 2025.; PRIA reads it as touching household money (as of 2026-11-02).

- Canonical: https://policyrisk.com/federal-register/2025-11028
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11028
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; [AVEIR VR LEADLESS SYSTEM]
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25321
- Published: 2025-06-16
- Effective: Anyone with knowledge that any of the dates as published may submit comments and ask for a redetermination by August 15, 2025. Any interested person may petition FDA for a determination regarding whether the applicant acted with due diligence during the regulatory review period by December 15, 2025.
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-02

## In one line

FDA Patent Review for a Pacemaker With No Leads

## Summary

The FDA has set the official review period for the AVEIR VR Leadless System, a cool medical device, so its makers can apply to extend their patent. If you think the dates are wrong or want to challenge how carefully the company worked during the review, you have until mid-2025 to speak up. This helps the company protect their invention longer, which could impact when others can make similar devices.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AVEIR VR Leadless System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

## Effects PRIA read

- FDA sets 3,109‑day review period for patent extension: benefit, high. FDA determined the regulatory review period for the AVEIR VR Leadless System is 3,109 days in total — 740 days in the testing phase and 2,369 days in the approval phase. This determination establishes the maximum potential length of a patent extension; the applicant is seeking 1,826 days of patent…
- AVEIR VR Leadless System approved for specific patients: benefit, high. FDA has approved the AVEIR VR Leadless System (PMA P150035) with approval dated March 31, 2022. It is indicated for patients with bradycardia (including normal sinus rhythm with rare A-V block or sinus arrest), chronic atrial fibrillation, and severe physical disability; Rate‑Modulated Pacing is in…

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## Sources
- [2025-11028 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11028/determination-of-regulatory-review-period-for-purposes-of-patent-extension-aveir-vr-leadless-system)
- [2025-11028 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11028.pdf)

## Related
- [Previous: 2025-11027, Agency Information Collection Activities: Submission for OMB Review; Comment Re…](https://policyrisk.com/federal-register/2025-11027)
- [Next: 2025-11029, Determination of Regulatory Review Period for Purposes of Patent Extension; XOL…](https://policyrisk.com/federal-register/2025-11029)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-11028 (as of 2026-11-02).