Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K821073 ↗

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

• 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 is the primary purpose of this Pulse Generator in a cardiac pacemaker system?

  This Pulse Generator acts as the power source and control unit for cardiac pacemakers, delivering timed electrical impulses to regulate abnormal heart rhythms. It stimulates the heart muscle to contract at an appropriate rate, ensuring proper cardiac function for patients with arrhythmias.

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

  While the device is designed for implantable use and is supplied sterile for surgical implantation, the data indicates it is typically intended as a single-use implant. However, specific models may vary in design and battery life, so it’s best to confirm the reuse policy with the manufacturer or consult the device’s technical documentation.

• How is this Pulse Generator supplied, and what does that mean for surgical preparation?

  The Pulse Generator is supplied sterile, meaning it is pre-packaged and ready for immediate use in surgical implantation without additional sterilization. This ensures a clean, sterile environment for the procedure, reducing the risk of infection.

• What regulatory pathway was followed for this Pulse Generator’s approval, and which committee reviewed it?

  This Pulse Generator was cleared through the FDA’s 510(k) pathway, specifically under the Traditional clearance type. It was reviewed by the Cardiovascular (CV) Advisory Committee, which evaluates devices intended for cardiovascular applications, including pacemakers.

• Are there different sizes or models of this Pulse Generator, and if so, how might they differ?

  The data does not specify exact sizes or models, but the device is classified under the FDA product code DXY, which covers Implantable Pacemaker Pulse-Generators. Variations in battery life, design, or programming capabilities may exist between models, so it’s important to verify the specific features of the model in question with the manufacturer or product documentation.