Lead Models MUM 1260, MUM 1290

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

510(k) Number

K790386 ↗

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

• 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

• 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 pacemaker leads designed for reuse or single-use, and what does that mean for my clinical workflow?

  The Lead Models MUM 1260 and MUM 1290 are explicitly intended for single-use implantation only. This means each lead is sterile upon receipt and should not be reused after one procedure. Clinically, this ensures patient safety by eliminating cross-contamination risks, and your workflow should account for proper disposal after use while maintaining sterile handling protocols throughout the procedure.

• What storage conditions are required to keep these leads sterile before use?

  Since these leads are supplied sterile, they must be stored and handled according to sterile medical device protocols to preserve their integrity. This typically includes keeping them in their original packaging, away from direct sunlight or extreme temperatures, and ensuring the sterile barrier remains uncompromised until implantation. Always follow the manufacturer’s instructions for storage to avoid compromising sterility.

• What are the key differences between the MUM 1260 and MUM 1290 models, and how do I choose between them?

  The data provided does not specify technical differences between the MUM 1260 and MUM 1290 models beyond their classification as permanent pacemaker electrodes. Selection should be based on clinical indication, patient anatomy, and compatibility with your pacing system. Consult your device specifications or manufacturer documentation for detailed technical distinctions, such as lead length, electrode configuration, or fixation mechanisms, as these are critical for proper implantation.

• How do I verify the regulatory compliance of these leads before use in my facility?

  These leads were cleared through the FDA’s 510(k) pathway in 1979 under product code DTB (Permanent Pacemaker Electrode) and are classified as Class 3 devices, regulated under 21 CFR 870.3680. To confirm compliance, check the FDA’s OpenFDA database using the provided FEI numbers or registration numbers (e.g., 2017865). Additionally, ensure your facility’s procurement process includes verification of the manufacturer’s sterility validation and adherence to sterile handling protocols, as required for Class 3 devices.