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Alternate Sterile Pkg Implantable Pulse Generators

FDA 510(k)

Class III (US FDA 510(k))

510(k) K854482

by Medtronic Vascular

Identifiers

510(k) Number
K854482 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 as a Class III medical device under FDA regulation 870.3610. It is designed to generate electrical pulses for pacing cardiac tissue, ensuring proper heart rhythm in patients with bradycardia or conduction disorders. The device is intended for implantation within the body to provide sustained pacing support.

The Alternate Sterile Package Implantable Pulse Generators are supplied in a sterile packaging configuration, intended for single-use implantation. Cleared under FDA 510(k) number K854482 in 1986, this device falls under the Cardiovascular medical specialty and was reviewed by the Cardiovascular (CV) advisory committee. No additional regulatory status beyond the stated FDA 510(k) clearance is implied. The product code assigned is DXY, and it adheres to traditional clearance pathways.

Frequently asked questions

What is the primary purpose of the Alternate Sterile Package Implantable Pulse Generators from Medtronic Vascular, and who would benefit from this device?

The Alternate Sterile Package Implantable Pulse Generators are designed to generate electrical pulses for pacing cardiac tissue, ensuring proper heart rhythm in patients with bradycardia or conduction disorders. This device is intended for implantation within the body to provide sustained pacing support, making it beneficial for individuals experiencing slow heart rhythms or irregular electrical activity in their hearts.

Are these pulse generators intended for single-use or reusable applications, and how are they supplied?

These pulse generators are supplied in a sterile packaging configuration specifically intended for single-use implantation. The sterile packaging ensures safety and sterility for one-time surgical use, eliminating the need for reprocessing or reuse.

What regulatory pathway was followed for the clearance of this device, and which advisory committee reviewed it?

This device was cleared under the FDA 510(k) pathway with the decision code SESE (Substantially Equivalent). It was reviewed by the Cardiovascular (CV) Advisory Committee and falls under the traditional clearance process. The product code assigned is DXY, and it adheres to the standard regulatory framework for Class III medical devices.

How many different models or variants of this pulse generator have been registered under this FDA clearance?

The FDA registration lists multiple FEI (Facility Establishment Identifier) numbers, indicating that this clearance covers several distinct models or variants of the Alternate Sterile Package Implantable Pulse Generators. These include identifiers like 3002807576, 2017865, and others, suggesting a range of configurations or sizes may be available under this classification.

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: Alternate Sterile Pkg Implantable Pulse Generators, Medtronic Vascular Alternate Sterile PKG Implantable Pulse…, Alternate Sterile Pkg Implantable Pulse Generators… - FDA.report, Alternate Sterile Pkg Implantable Pulse Generators

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K854482 24 fields · synced Oct 6, 2026