Medtronic Model 4558M Permanent Pacemaker Electrode
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K940703 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3680 FDA 510(k)
- Regulation Number
- 870.3680 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESP Substantially Equivalent — Postmarket Surveillance FDA 510(k)
The Medtronic Model 4558M is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system to facilitate cardiac pacing. This device delivers electrical impulses to regulate heart rhythm in patients with bradycardia or other conduction disorders, ensuring consistent and reliable cardiac function.
This electrode is intended for single-use implantation by trained medical professionals in clinical settings such as hospitals or cardiac care units. Supplied sterile and intended for direct contact with cardiac tissue, it adheres to FDA 510(k) clearance standards under classification III (DTB). Compliance with regulatory requirements ensures safe integration into pacemaker systems for long-term cardiac support.
Frequently asked questions
What is the Medtronic Model 4558M used for in clinical practice?
The Medtronic Model 4558M is a permanent pacemaker electrode designed to be implanted in the cardiovascular system to deliver electrical impulses. It regulates heart rhythm in patients with bradycardia or conduction disorders, ensuring consistent cardiac function over the long term. This device is intended for single-use implantation by trained professionals in controlled settings like hospitals or cardiac care units.
Is the Medtronic Model 4558M intended for reuse or single-use, and how is it supplied?
The Medtronic Model 4558M is explicitly intended for single-use implantation only. It is supplied sterile, ensuring it is ready for direct contact with cardiac tissue without risk of contamination. This design aligns with clinical best practices for pacemaker electrodes to maintain patient safety and device efficacy.
What regulatory pathway was followed for FDA clearance of this device?
The Medtronic Model 4558M underwent a traditional 510(k) clearance process through the FDA, classified under Classification III (DTB) for permanent pacemaker electrodes. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and received clearance on November 4, 1994, under K940703. This pathway ensures compliance with stringent safety and performance standards for devices intended for long-term cardiac support.
How should the Medtronic Model 4558M be stored before use?
While the exact storage instructions aren’t detailed in the provided data, the device is sterile at time of supply, which implies it should be stored in its original, unopened packaging in a clean, dry environment—protected from moisture, extreme temperatures, and physical damage. Proper storage ensures sterility and integrity until single-use implantation by trained medical professionals.
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 | K940703 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K940703 24 fields · synced Oct 6, 2026