Opus Pulse Generators Models 3001, 3003, and 3004

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

510(k) Number

K882476 ↗

FDA Product Code

DXY

Models / Variants

3001

3003

3004

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

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• What are the key differences between the Opus Pulse Generator Models 3001, 3003, and 3004 in terms of their functionality?

  The Opus Pulse Generators Models 3001, 3003, and 3004 are differentiated by their internal programming and pacing capabilities, though the exact distinctions between them are not detailed in the provided data. All three models are designed as implantable pacemaker pulse-generators to regulate abnormal heart rhythms like bradycardia or heart block by delivering electrical impulses. The variations in programming likely influence pacing algorithms, response thresholds, or other clinical settings, but the data does not specify these differences.

• Are these devices intended for reuse, or are they meant to be implanted only once?

  The Opus Pulse Generators Models 3001, 3003, and 3004 are explicitly described as intended for single-use implantation. They are supplied sterile and designed to be implanted subcutaneously once per patient, after which they are not intended to be removed or reused.

• How are these devices regulated by the FDA, and what does the product code DXY signify?

  These devices are regulated under the FDA’s 510(k) clearance process (with clearance number K882476) and fall under product code DXY, which categorizes them as Implantable Pacemaker Pulse-Generators. The classification aligns with FDA regulation number 870.3610, confirming they are Class III medical devices—the highest regulatory category for devices requiring pre-market approval due to their critical role in patient safety and efficacy.

• What storage or handling considerations should be taken into account for these devices before implantation?

  While the data does not specify exact storage conditions, the devices are supplied sterile and intended for single-use implantation. Standard sterile packaging practices should be followed to maintain integrity until use. Since they are implanted subcutaneously, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve functionality and sterility.

• What is the primary clinical purpose of these Opus Pulse Generator models, and for which patients are they intended?

  These devices are intended for patients requiring artificial pacing to correct abnormal heart rhythms, such as bradycardia (slow heart rate) or heart block (blocked electrical signals). They deliver electrical impulses to regulate cardiac rhythm and are designed for implantation in patients whose natural pacing mechanisms are insufficient or non-functional, as determined by a clinician.