Neos LP Implantable Pacemaker Pulse-Generator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Neos LP

510(k) Number

K841633 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  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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  FDA 510(k) K841635 Active Cleared 3 Aug 1984

• EDP-20 Pacemaker

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• Pulse Generator

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  FDA 510(k) K821073 Active Cleared 7 May 1982

• Biotronik Permanent Pacemaker Electrode

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  FDA 510(k) K863480 Active Cleared 23 Sep 1986

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• What is the Neos LP used for in clinical practice?

  The Neos LP is an implantable pacemaker pulse-generator designed to treat patients with bradycardia or conduction disorders by delivering electrical impulses to maintain a regular heart rhythm. It is intended for single-use implantation and requires surgical placement to function as intended.

• How is the Neos LP supplied, and is it reusable?

  The Neos LP is supplied sterile and intended for single-use only. It is not designed for reuse after implantation, as it is classified as a Class III medical device with a one-time implantation purpose.

• What regulatory pathway was followed for FDA clearance of the Neos LP?

  The Neos LP received FDA clearance through the 510(k) pathway with a traditional review, classified as substantially equivalent (SESE) under FDA regulations. The device was reviewed by the Cardiovascular (CV) advisory committee and assigned product code DXY.

• Are there any specific storage requirements mentioned for the Neos LP?

  The provided data does not specify storage requirements for the Neos LP, but since it is supplied sterile and intended for surgical implantation, standard sterile medical device storage guidelines should be followed to maintain integrity until use.