Medical Multilith Pulse Genera-1140

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

510(k) Number

K813246 ↗

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 Medical Multilith Pulse Generator 1140 used for in clinical practice?

  The Medical Multilith Pulse Generator 1140 is designed to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders by delivering electrical impulses to the heart. It functions as an implantable pacemaker, ensuring consistent cardiac pacing when the natural conduction system fails.

• Is the Medical Multilith Pulse Generator 1140 intended for reuse or single-use?

  The device is explicitly intended for single-use implantation only. It must be handled under aseptic conditions prior to use and is supplied sterile to ensure patient safety and sterility integrity.

• How should the Medical Multilith Pulse Generator 1140 be stored before implantation?

  Storage and handling must comply with FDA guidelines for implantable cardiac devices. The device is sterile upon receipt, so it should be kept in its original packaging until ready for use, protected from contamination and environmental exposure.

• Can the Medical Multilith Pulse Generator 1140 be used in patients requiring MRI scans?

  No, the device is MRI-unsafe and should not be exposed to magnetic fields. This is due to potential interference with its function or damage from MRI environments, posing risks to the patient.

• What regulatory pathway was followed for FDA clearance of the Medical Multilith Pulse Generator 1140?

  The device underwent a traditional 510(k) review pathway with the FDA, classified as a Class III device (life-sustaining/life-supporting). It was determined substantially equivalent to a predicate device, with clearance number K813246, and reviewed by the Cardiovascular (CV) Advisory Committee.