Neos-M VS-1 Pulse Generator

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

510(k) Number

K863879 ↗

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

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  FDA 510(k) K833104 Active Cleared 19 Oct 1983

• Leptos Implantable Pacemaker Pulse-Generator

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• EDP-20 Pacemaker

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  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 NEOS-M VS-1 Pulse Generator, and how does it function in a patient’s heart?

  The NEOS-M VS-1 Pulse Generator is designed to regulate heart rhythm in patients with bradycardia or cardiac conduction disorders by delivering electrical impulses. It acts as the power source and control unit for pacing systems, ensuring consistent and reliable cardiac stimulation to maintain a proper heartbeat.

• Is the NEOS-M VS-1 Pulse Generator intended for reuse, or is it meant for single-use implantation?

  The device is explicitly intended for single-use implantation after surgical placement by a healthcare professional. It is not designed for reuse, and proper sterile techniques must be followed during implantation.

• How is the NEOS-M VS-1 Pulse Generator supplied, and what precautions should be taken during handling?

  The device is supplied sterile and requires surgical implantation under sterile conditions. Since it is intended for single-use, it should only be handled in a clean, controlled environment to prevent contamination before and during the procedure.

• What regulatory pathway was followed for the NEOS-M VS-1 Pulse Generator, and what classification does it hold?

  The NEOS-M VS-1 Pulse Generator was cleared through the FDA 510(k) process under the Traditional pathway and is classified as a Class III medical device (product code DXY). It was determined to be substantially equivalent to a predicate device and is regulated under 21 CFR 870.3610 for cardiovascular applications.