NOMOS-01 Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K800375 ↗

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 Nomos-01 Pulse Generator and for which patients is it intended?

  The Nomos-01 Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients who require artificial cardiac pacing to correct bradycardia or conduction disorders, ensuring proper heart function when the natural pacemaker fails.

• Is the Nomos-01 Pulse Generator reusable or single-use, and how should it be stored?

  The Nomos-01 Pulse Generator is a sterile, single-use implantable device. It must be stored and handled according to sterile medical device protocols to maintain its integrity before surgical implantation by qualified healthcare professionals.

• What regulatory pathway was followed for FDA clearance of the Nomos-01 Pulse Generator?

  The Nomos-01 Pulse Generator received FDA clearance through a 510(k) submission, specifically under the traditional clearance type. It was determined to be substantially equivalent to a predicate device by the Cardiovascular (CV) Advisory Committee, with clearance number K800375.

• How is the Nomos-01 Pulse Generator classified under FDA regulations, and what does this mean for its use?

  The Nomos-01 Pulse Generator is classified as a Class III medical device under FDA regulations, which means it is subject to stringent controls due to its high-risk nature. This classification ensures rigorous evaluation of safety and effectiveness before use in patients requiring artificial cardiac pacing.