Multilith 2 Pulse Generator 1141 & 2141

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

510(k) Number

K842220 ↗

FDA Product Code

DXY

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. →

• What is the primary purpose of the Multilith 2 Pulse Generator 1141 & 2141, and how does it function in clinical practice?

  The Multilith 2 Pulse Generator 1141 & 2141 is designed to deliver electrical impulses for cardiac rhythm management, specifically for patients requiring pacing therapy. It functions as an implantable pacemaker, correcting abnormal heart rhythms by stimulating the heart muscle to contract at a proper rate and rhythm, ensuring consistent cardiac function.

• Is the Multilith 2 Pulse Generator reusable or single-use, and what handling precautions should be taken during surgical implantation?

  The Multilith 2 Pulse Generator is a reusable, implantable device, meaning it is intended for multiple uses after proper sterilization and maintenance. Since it is implanted surgically, it must be handled under sterile conditions to prevent infection, adhering to standard cardiovascular medical specialty protocols.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

  The Multilith 2 Pulse Generator 1141 & 2141 received FDA clearance through a traditional 510(k) review pathway, classified under the Implantable Pacemaker Pulse-Generator category. The review was conducted by the Cardiovascular (CV) Advisory Committee, ensuring compliance with FDA standards for cardiovascular devices.

• What are the key specifications or distinctions between the 1141 and 2141 models, if any, based on the provided data?

  The provided data does not specify distinct clinical or technical differences between the 1141 and 2141 models beyond their classification as part of the same pulse generator system. Both are intended for the same purpose—delivering pacing therapy—and share the same regulatory and procedural pathways. Further details would require manufacturer documentation.