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Implantable Pulse-Generator Devices

FDA 510(k)

Class III (US FDA 510(k))

510(k) K903919

by Medtronic Vascular

Identifiers

510(k) Number
K903919 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)

The Implantable Pulse-Generator Devices are classified as Implantable Pacemaker Pulse-Generators, a Class III medical device designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are intended for patients with bradycardia or other cardiac conduction disorders requiring chronic pacing support, ensuring consistent and reliable heart function.

These devices are implanted subcutaneously or within the thoracic cavity and are supplied sterile for single-use implantation. They are regulated under FDA 510(k) clearance (K903919) and fall under the medical specialty of cardiovascular care. Device sizes and models vary, as indicated by the registration numbers (e.g., 2017865, 3005334138), and are intended for use in controlled clinical settings with appropriate surgical and post-operative monitoring.

Frequently asked questions

What clinical conditions are these implantable pulse devices designed to address, and how do they work?

These devices are specifically designed to treat bradycardia (slow heart rate) and other cardiac conduction disorders that require chronic pacing support. They work by delivering controlled electrical impulses to the heart through implanted leads, ensuring consistent and reliable heart rhythm regulation. The devices are implanted either subcutaneously or within the thoracic cavity to provide continuous pacing support.

Are these devices intended for single-use or can they be reused after implantation?

These devices are sterile and supplied for single-use only, meaning each unit is intended for one-time implantation in a patient. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.

How many different models or sizes are available, and how can I identify them?

Multiple models are available, each identified by unique registration numbers (e.g., 2017865, 3005334138, 3004593495). These numbers correspond to specific device configurations, which may vary in features like battery life, pacing capabilities, or lead compatibility. The manufacturer’s documentation or ordering system should be consulted to confirm the exact model details for a given application.

What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians?

These devices were cleared via the FDA 510(k) pathway (K903919), with a substantially equivalent (SESE) determination under the Cardiovascular (CV) advisory committee. This means the device was evaluated as comparable to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for implantable pacemaker pulse-generators. Clinicians can rely on this clearance as part of their decision-making process for appropriate patient care.

How should these devices be stored before implantation, and what precautions should be taken?

Since these devices are sterile and single-use, they must be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediately before use to maintain sterility. Any damaged or compromised packaging should be discarded, and a new sterile unit used.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K903919 24 fields · synced Oct 6, 2026