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Medtronic Models 8320/8322/8329 Implantable Pacemaker Pulse-Generator - 8322

FDA 510(k)

Class III (US FDA 510(k))

510(k) K852688

by Medtronic Vascular

Identifiers

510(k) Number
K852688 FDA 510(k)
FDA Product Code
DXY FDA 510(k)
Models / Variants
8320 FDA 510(k)
8322 FDA 510(k)
8329 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)

The Medtronic Models 8320/8322/8329 are implantable pacemaker pulse-generators, classified under the nomenclature for Class III cardiovascular devices. These devices incorporate a power supply and electronic circuits designed to generate periodic electrical pulses, stimulating cardiac tissue to maintain proper heart rhythm in patients requiring pacing support.

These models are intended for surgical implantation and are regulated under FDA 510(k) clearance (K852688) as a Class 3 device, falling under product code DXY. Supplied sterile and intended for single-use implantation, they are designed for use in cardiovascular procedures and require adherence to sterile techniques during handling and deployment. Authorized for use in the United States, these devices were cleared through the Traditional 510(k) pathway in 1985.

Frequently asked questions

Are these pacemaker pulse generators designed for reuse or intended as single-use devices, and how does that affect handling during surgery?

These Medtronic Models 8320/8322/8329 are sterile and intended for single-use implantation only. Since they are implanted surgically, they must remain unopened until deployment to maintain sterility. Reuse is not permitted, and any unused device must be discarded per sterile technique protocols to prevent contamination.

What types of cardiac conditions or patients would these devices be used for, and how do they work?

These devices are implantable pacemaker pulse-generators designed to stimulate cardiac tissue and maintain proper heart rhythm in patients requiring pacing support. They generate periodic electrical pulses to address conditions like bradycardia (slow heart rate) or conduction system disorders, ensuring consistent cardiac contractions when the heart’s natural rhythm is insufficient.

How are these devices regulated in the U.S., and what does the FDA clearance indicate about their safety and equivalence?

These devices were cleared through the FDA’s Traditional 510(k) pathway (K852688) in 1985 under product code DXY, classified as Class III cardiovascular devices. The clearance indicates they were determined to be substantially equivalent (SESE) to a legally marketed predicate device, meaning the FDA found their design and performance to meet established safety and effectiveness standards for pacemaker pulse-generators.

Are there multiple models available, and if so, how do they differ in terms of specifications or intended use?

Yes, these devices include three models (8320, 8322, 8329), but the provided data does not specify distinct clinical differences between them. All are implantable pacemaker pulse-generators cleared under the same 510(k) submission (K852688), suggesting they may vary in technical specifications (e.g., battery life, pacing modes) rather than intended clinical applications. For precise model distinctions, consult Medtronic’s technical documentation.

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: MEDTRONICS MODELS 8320/8322/8329 (K852688) — FDA 510 (k) - Innolitics, K852688 FDA 510(k) - MEDTRONICS MODELS 8320/8322/8329, Medtronic Vascular Medtronics Models 8320/8322/8329

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K852688 24 fields · synced Sep 18, 2026