Opus 3 Pulse Generators Models 4003, 4004, 4023, 4024

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K882391 ↗

FDA Product Code

DXY

Models / Variants

4003

4004

4023

4024

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacing Lead #PMA F 860

  Class III

  FDA 510(k) K830457 Active Cleared 17 Mar 1983

• Opus Pulse Generators Models 2001, 2003, and 2004

  Class III

  FDA 510(k) K882474 Active Cleared 12 Sep 1988

• Lead Models MUM 1260, MUM 1290

  Class III

  FDA 510(k) K790386 Active Cleared 3 Apr 1979

• Focus J81F, J83F, J41F, J43F Pacing Leads

  Class III

  FDA 510(k) K896742 Active Cleared 17 Jul 1990

• Focus T41, T41F, T43, T43F, T44F

  Class III

  FDA 510(k) K904255 Active Cleared 18 Jan 1991

• Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

See all devices from Ela Medical, Inc. →

• Are these Opus 3 Pulse Generators designed for reuse in a clinical setting, or are they intended for single-use only?

  The Opus 3 Pulse Generators (Models 4003, 4004, 4023, and 4024) are explicitly designed for single-use within the body after surgical implantation. They are supplied sterile and intended to remain implanted long-term, providing continuous electrical impulses to regulate heart rhythm, so reuse is not applicable or recommended.

• What types of heart conditions are these devices intended to address, and how do they work?

  These pulse generators are intended for patients with bradycardia or other cardiac conduction disorders, where the heart’s natural electrical system fails to maintain a proper rhythm. They deliver regulated electrical impulses to stimulate the heart muscle, ensuring consistent cardiac output and restoring normal heart function by compensating for the body’s inability to generate adequate electrical signals on its own.

• How are these devices supplied, and what precautions should be taken during handling?

  The Opus 3 Pulse Generators are supplied sterile and packaged for direct implantation in a controlled clinical environment. Since they are intended for surgical implantation, they must be handled using aseptic techniques to prevent contamination. The sterile packaging ensures they are ready for immediate use once opened, minimizing the risk of infection during the procedure.

• What regulatory pathway was followed for FDA clearance of these devices, and which committee reviewed the submission?

  The Opus 3 Pulse Generators received FDA 510(k) clearance under the Traditional Review pathway, demonstrating they are substantially equivalent to a legally marketed predicate device. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, which specializes in evaluating cardiovascular devices like implantable pacemaker pulse generators, ensuring compliance with safety and effectiveness standards.

• Are there different models available, and if so, how might they differ in terms of functionality or intended use?

  Yes, there are four models: 4003, 4004, 4023, and 4024. While the exact functional differences between them are not detailed in the provided data, the models are all classified under the same product code (DXY) and regulatory category (Implantable Pacemaker Pulse-Generator). Clinicians should refer to manufacturer documentation for specific programming capabilities, battery life, or pacing modes that may vary by model to determine the best fit for a patient’s needs.