Neos-LP Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844842 ↗

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 types of patients is the NEOS-LP Pulse Generator designed to support, and how does it function in their care?

  The NEOS-LP Pulse Generator is designed for patients requiring cardiac rhythm management, specifically those with conditions like bradycardia or heart block where the heart beats too slowly or irregularly. It delivers consistent electrical impulses to maintain a normal heart rhythm, ensuring proper cardiac function. This device is intended for both temporary and permanent use as part of a pacemaker system, helping to regulate heart rate and maintain synchronization in patients who rely on pacing support.

• Is the NEOS-LP Pulse Generator reusable, or is it intended for single-use implantation, and what does that mean for replacement or upgrades?

  The NEOS-LP Pulse Generator is supplied sterile and intended for single-use implantation, though it may be reprogrammable or replaceable as part of a pacemaker system. This means it is not designed for reuse after initial use but can be replaced or upgraded if clinical needs change or if the device requires maintenance or updating over time. Replacement would follow standard medical procedures for implantable cardiac devices.

• How should the NEOS-LP Pulse Generator be stored, and what precautions should be taken to ensure its integrity before use?

  The NEOS-LP Pulse Generator must be stored according to the manufacturer’s guidelines for sterile, implantable devices. This typically involves keeping it in its original packaging, in a clean, dry environment, and away from extreme temperatures or direct sunlight. Proper storage ensures sterility and functionality before implantation, as it is supplied sterile and intended for single-use procedures.

• What regulatory pathway does the NEOS-LP Pulse Generator follow, and how does this affect its use in clinical settings?

  The NEOS-LP Pulse Generator is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K844842, and falls under the classification of an Implantable Pacemaker Pulse-Generator (product code DXY). This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for use in cardiac pacing. Clinicians should verify MRI safety compliance before use, as required for implantable devices.

• Are there different models or sizes available for the NEOS-LP Pulse Generator, and if so, how might a clinician determine the appropriate one for a patient?

  The provided data does not specify distinct models or sizes for the NEOS-LP Pulse Generator, but pacemaker systems typically offer variations to accommodate different patient anatomies or clinical needs. A clinician would determine the appropriate device based on factors like patient size, lead configuration, and specific pacing requirements. Consultation with the manufacturer’s guidelines or technical support would be essential to ensure compatibility and optimal performance for the patient’s condition.