EDP-20 Pacemaker

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

510(k) Number

K860036 ↗

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

• 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

See all devices from Biotronik Sales, Inc. →

• What is the primary clinical purpose of the EDP-20 Pacemaker and how does it function in patients?

  The EDP-20 Pacemaker is designed to regulate heart rhythm by delivering controlled electrical impulses to the heart muscle when the natural pacemaker fails. It is specifically intended for patients with bradycardia or conduction disorders, helping maintain proper cardiac function by ensuring the heart beats at an appropriate rate.

• Is the EDP-20 Pacemaker intended for single-use or reusable applications, and how should it be handled post-implantation?

  The EDP-20 Pacemaker is supplied as a sterile, single-use implant. Once implanted, it is not intended for reuse, and proper sterile procedures must be followed during surgery to ensure patient safety and device functionality.

• What regulatory pathway was followed for the EDP-20 Pacemaker, and what does this mean for its use in clinical settings?

  The EDP-20 Pacemaker was cleared through the FDA’s 510(k) process, specifically under a decision classification of *Substantially Equivalent* to a predicate device. This means it was determined to have the same intended use, technological characteristics, and performance as a legally marketed device, ensuring it meets regulatory standards for safety and effectiveness in cardiovascular settings.

• How is the EDP-20 Pacemaker supplied, and what precautions should be taken during storage or handling?

  The EDP-20 Pacemaker is supplied sterile and intended for surgical implantation only. Since it is single-use, it should be stored in its original packaging until ready for use, protected from contamination, moisture, and physical damage. Proper sterile handling is critical to maintain device integrity before implantation.

• What types of medical professionals are qualified to implant the EDP-20 Pacemaker, and where would this procedure typically take place?

  The EDP-20 Pacemaker must be implanted by qualified medical professionals, such as cardiologists or electrophysiologists, in a controlled cardiovascular setting like a hospital operating room or cardiac catheterization lab. The procedure requires adherence to sterile techniques to ensure patient safety and device functionality.