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Models 8420 Thru 8423 Pacemaker Gener

FDA 510(k)

Class III (US FDA 510(k))

510(k) K810734

by Medtronic Vascular

Identifiers

510(k) Number
K810734 FDA 510(k)
FDA Product Code
DXY FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3610 FDA 510(k)
Regulation Number
870.3610 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an Implantable Pacemaker Pulse-Generator, classified under product code DXY. It is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate rate or rhythm, thereby supporting cardiac function in patients with bradycardia or conduction disorders.

The Models 8420 Through 8423 Pacemaker Generator is intended for surgical implantation and is classified as a Class III device under FDA regulations (870.3610). It was granted FDA 510(k) clearance (K810734) in 1981, following review by the Cardiovascular (CV) Advisory Committee. The device is supplied sterile and intended for single-use implantation, with no indication of MRI compatibility or reusable components. Authorized under Medtronic Vascular’s submission, it adheres to cardiovascular medical specialty standards.

Frequently asked questions

What is the primary clinical purpose of the Models 8420–8423 Pacemaker Generator, and how does it address patient needs?

This device is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate rate or rhythm. It is specifically intended for patients with bradycardia (slow heart rate) or conduction disorders, helping to maintain stable cardiac function by compensating for irregularities in the heart’s electrical activity.

Is this pacemaker generator intended for reuse, or is it meant to be implanted as a single-use device?

The Models 8420–8423 Pacemaker Generator is explicitly supplied sterile and intended for single-use implantation only. It is not designed for reuse or reprocessing, ensuring patient safety and compliance with medical device standards for implantable cardiac devices.

What regulatory pathway was followed for FDA clearance of this pacemaker, and which advisory committee reviewed the submission?

This device received FDA 510(k) clearance (K810734) under the Traditional 510(k) Review pathway, with a determination of Substantially Equivalent to a predicate device. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III device under FDA regulations (870.3610).

Are there multiple models within this series, and if so, how are they differentiated?

Yes, the series includes Models 8420 through 8423, though the provided data does not specify technical or functional distinctions between them. The differentiation may relate to internal programming, lead compatibility, or battery specifications—details typically outlined in the manufacturer’s technical documentation or labeling. Always verify compatibility with your clinical needs before selection.

How should this pacemaker generator be stored prior to implantation, given its sterile and single-use nature?

Since the device is supplied sterile and intended for single-use, it must be stored in its original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment, protected from extreme temperatures, moisture, and physical damage. Follow the manufacturer’s instructions for storage duration and conditions to ensure device integrity before implantation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MODELS 8420 THRU 8423 PACEMAKER GENER - Innolitics, K810734 - MODELS 8420 THRU 8423 PACEMAKER GENER | FDA 510(k), K810734 - MODELS 8420 THRU 8423 PACEMAKER GENER | FDA 510(k), Medtronic Vascular Models 8420 Thru 8423 Pacemaker Gener

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K810734 24 fields · synced Oct 6, 2026