Leptos Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844794 ↗

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

• Leptos Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K841635 Active Cleared 3 Aug 1984

• 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

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• What is the primary purpose of the Leptos Pulse Generator in a clinical setting?

  The Leptos Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients requiring permanent pacing to correct bradycardia or other conduction disorders. It ensures consistent and reliable cardiac function in patients who need chronic support for their heart’s electrical activity.

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

  The Leptos Pulse Generator is explicitly described as a reusable component within a pacemaker system. It is intended to be implanted permanently and is not designated for single-use, aligning with typical practices for implantable pacemaker pulse-generators.

• How is the Leptos Pulse Generator regulated by the FDA, and what does that mean for its use?

  The Leptos Pulse Generator is regulated under FDA 510(k) clearance (K844794) as substantially equivalent to prior generations, classified as a Class III medical device. This means it has undergone a review process to demonstrate safety and effectiveness, ensuring it meets regulatory standards for use in clinical settings by trained healthcare professionals.

• Are there any specific guidelines mentioned for handling or storing the Leptos Pulse Generator before implantation?

  The data does not specify sterility requirements or detailed storage guidelines for the Leptos Pulse Generator. However, as an implantable device, it must adhere to sterile implantation protocols, which are standard for Class III devices to prevent infection during surgery.

• What types of patients is the Leptos Pulse Generator intended for, and how is it typically used?

  The Leptos Pulse Generator is intended for patients with bradycardia or conduction disorders who require permanent pacing. It is used in clinical settings by trained healthcare professionals to deliver electrical impulses to the heart, ensuring stable cardiac rhythm. The device is part of a larger pacemaker system and is implanted surgically.