Opus S Model 4121 and 4124 Pacemakers

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

510(k) Number

K970072 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

ST

• 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 the Opus S Model 4121 and 4124 pacemakers designed for single-use or can they be reused after implantation?

  The Opus S Model 4121 and 4124 pacemakers are supplied sterile for implantation, which implies they are intended for single-use. Implantable pulse-generators like these are not designed for reuse due to the risk of infection and device malfunction over time. Sterile packaging ensures safe, one-time use in a clinical setting.

• What specific cardiac pacing parameters can be programmed into the Opus S Model 4121 and 4124 pacemakers?

  The Opus S Model 4121 and 4124 pacemakers allow programmable parameters including pacing rate, amplitude (output strength), pulse width (duration of electrical stimulation), and sensitivity (threshold for detecting intrinsic heart signals). These settings are adjusted to match the patient’s clinical needs and ensure proper cardiac pacing therapy.

• How are these pacemakers classified under FDA regulations, and what does that mean for tracking and compliance?

  The Opus S Model 4121 and 4124 pacemakers are classified as Class III devices under FDA regulation 870.3610, which applies to implantable pacemaker pulse-generators. This classification means they are subject to mandatory premarket approval (or 510(k) clearance, as granted here) and tracking requirements—meaning each unit must be recorded in the FDA’s registry for post-market surveillance. This ensures rigorous oversight of their safety and performance.

• What is the intended use of the Opus S Model 4121 and 4124 pacemakers, and how do they differ from multi-chamber models?

  These devices are single-chamber pacemakers, meaning they deliver pacing therapy to one heart chamber (either the atrium or ventricle) via an implanted lead. Unlike multi-chamber pacemakers, which coordinate pacing between both atria and ventricles, the Opus S models focus on basic rate support and timing of electrical impulses in a single pathway. They are ideal for patients requiring straightforward single-chamber pacing.

• What storage or handling instructions should be followed for the Opus S Model 4121 and 4124 pacemakers before implantation?

  While the provided data does not specify exact storage conditions, sterile implantable devices like these typically require protection from contamination and proper temperature control (usually room temperature, away from direct sunlight or extreme humidity). The sterile packaging must remain intact until use, and the device should be handled using aseptic techniques to prevent compromise of sterility before implantation.