Model 5985 Pacemaker Pulse Generator
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K800285 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 Model 5985 Pacemaker Pulse Generator is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate heart rhythm by generating electrical impulses. It is intended for patients with bradycardia or other cardiac conduction disorders requiring artificial pacing to maintain proper heart function.
This device is supplied sterile and intended for single-use implantation within the human body. It is regulated under FDA 510(k) clearance (K800285) and falls under the Cardiovascular advisory committee classification. The pulse generator is non-MRI-compatible and must be handled with sterile techniques prior to implantation, adhering to standard surgical protocols for cardiac devices.
Frequently asked questions
What is the primary purpose of the Model 5985 Pacemaker Pulse Generator and who is it designed for?
The Model 5985 Pacemaker Pulse Generator is designed to regulate heart rhythm by generating electrical impulses, specifically for patients with bradycardia or other cardiac conduction disorders. It is intended for individuals who require artificial pacing to maintain proper heart function, ensuring their heart beats at an appropriate rate.
Is the Model 5985 Pacemaker Pulse Generator reusable or intended for single-use, and how should it be handled before implantation?
The Model 5985 Pacemaker Pulse Generator is intended for single-use implantation within the human body. Due to its sterile packaging, it must be handled using sterile techniques prior to implantation, following standard surgical protocols for cardiac devices to prevent contamination.
Can this device be used in an MRI environment, and what safety precautions should be taken during handling?
The Model 5985 Pacemaker Pulse Generator is non-MRI-compatible, meaning it should never be exposed to MRI environments. Since it is implanted within the body, strict adherence to manufacturer guidelines and surgical protocols is required to ensure patient safety during and after implantation.
What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?
The Model 5985 Pacemaker Pulse Generator received FDA 510(k) clearance under the traditional review pathway, with a decision classification of *Substantially Equivalent*. It was reviewed by the Cardiovascular (CV) Advisory Committee, which evaluates cardiovascular devices like pacemakers to ensure safety and effectiveness.
What product code and regulatory classification does this device fall under in the FDA database?
This device is classified under the FDA product code DXY and falls within the Class III regulatory category, which applies to high-risk medical devices like implantable pacemakers. The device is also regulated under the regulation number 870.3610, which pertains to pacemaker systems.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K800285 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K800285 24 fields · synced Oct 6, 2026