Focus J81F, J83F, J41F, J43F Pacing Leads

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

510(k) Number

K896742 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

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 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

• Opus Models 4033 and 4034 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K894267 Active Cleared 20 Sep 1989

See all devices from Ela Medical, Inc. →

• Are these pacing leads reusable or intended for single-use after implantation, and how does sterility factor into that decision?

  These leads (J81F, J83F, J41F, J43F) are explicitly designed for single-use implantation only. They are supplied sterile by the manufacturer, Ela Medical, ensuring they meet infection control standards for one-time cardiovascular use. Reuse is not recommended or supported by the design or regulatory classification as permanent pacemaker electrodes.

• What are the key differences between the J81F/J83F models and the J41F/J43F models in terms of intended use or features?

  The provided data does not specify technical differences between the J81F/J83F and J41F/J43F models beyond their classification as permanent pacemaker electrodes for cardiac pacing. Both sets are regulated under the same FDA 510(k) clearance (K896742) and product code (DTB), implying they share core functionality for electrical heart stimulation. For precise model-specific features (e.g., electrode type, lead length, or fixation mechanism), refer to the manufacturer’s technical documentation.

• How should these leads be stored to maintain their sterility and performance before use?

  While the data does not detail specific storage instructions, sterile medical devices like these leads typically require sealed, sterile packaging and protection from contamination. Store them in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use. Always follow Ela Medical’s included instructions for unpacking and handling to preserve sterility and functionality.

• What regulatory pathway was followed for FDA clearance of these pacing leads, and which advisory committee was involved?

  These leads were cleared via the traditional 510(k) pathway under FDA’s Cardiovascular (CV) Advisory Committee. The submission was deemed substantially equivalent (SESE) to a predicate device, with clearance granted on July 17, 1990 (decision code: SESE). The product code (DTB) and regulation number (870.3680) further confirm their classification as permanent pacemaker electrodes under Class 3 medical devices.