Leptos Implantable Pacemaker Pulse-Generator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Leptos

510(k) Number

K841635 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Biotronik DN Unipolar PE-60/4-DN Electrode

  Class III

  FDA 510(k) K833098 Active Cleared 19 Oct 1983

• Biotronik D2K Unipolar PE-60/4

  Class III

  FDA 510(k) K833104 Active Cleared 19 Oct 1983

• EDP-20 Pacemaker

  Class III

  FDA 510(k) K860036 Active Cleared 12 Jan 1987

• Pulse Generator

  Class III

  FDA 510(k) K821073 Active Cleared 7 May 1982

• Biotronik Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K863480 Active Cleared 23 Sep 1986

• Neos-M VS-1 Pulse Generator

  Class III

  FDA 510(k) K863879 Active Cleared 10 Dec 1986

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• What types of heart conditions is the Leptos pacemaker designed to treat, and how does it work?

  The Leptos is designed for patients with bradycardia or conduction disorders that require chronic pacing support. It functions as an implantable pulse-generator that delivers regulated electrical impulses to the heart muscle, either as a standalone device or as a backup system within a pacing therapy regimen. This helps maintain a normal heart rhythm by compensating for slow or irregular electrical signals.

• Is the Leptos pacemaker intended for single-use or can it be reused after implantation?

  The Leptos is explicitly labeled as a single-use device. It is intended for sterile surgical implantation by qualified medical professionals and should not be reused after implantation to ensure patient safety and sterility.

• Can the Leptos pacemaker be used in patients who require MRI scans, and why?

  No, the Leptos pacemaker is not MRI-safe. This is because MRI machines generate strong magnetic fields and radiofrequency waves that could interfere with the device’s function or cause damage to the pacemaker itself. Its use must be restricted to controlled clinical settings without MRI exposure.

• What storage and handling requirements apply to the Leptos pacemaker before implantation?

  The Leptos must be stored and handled according to sterile medical device protocols, as it is supplied in a sterile package for surgical implantation. Proper storage ensures its integrity and sterility before use, which is critical for preventing infection and ensuring safe implantation.

• How is the Leptos pacemaker regulated in the U.S., and what does that mean for clinicians?

  The Leptos is authorized under FDA 510(k) clearance (K841635) and classified as a Class III cardiovascular device under product code DXY. This means it undergoes rigorous review by the FDA to ensure safety and effectiveness, and clinicians can rely on its compliance with regulatory standards for implantable pacemakers. The device’s clearance indicates it is deemed substantially equivalent to a predicate device already on the market.