Medtronic Models 4011 & 4511 Permanent Pacemaker Electrode
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K822781 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
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Models 4011 & 4511 are permanent pacemaker electrodes, designed for implantation to provide electrical stimulation for cardiac pacing. These devices are intended for use in patients requiring chronic cardiac rhythm management, delivering consistent pacing signals to regulate heart function.
These electrodes are supplied sterile and intended for single-use implantation in a clinical setting. They are classified as Class III medical devices under FDA regulations (870.3680) and were cleared through the 510(k) pathway in 1982. The devices are manufactured by Medtronic Vascular and are intended for use in cardiovascular procedures, adhering to strict regulatory standards for permanent pacemaker leads.
Frequently asked questions
What is the primary clinical purpose of the Medtronic Models 4011 & 4511 electrodes, and how do they function in the body?
The Medtronic Models 4011 & 4511 are permanent pacemaker electrodes designed to provide chronic electrical stimulation for cardiac pacing. They are implanted to deliver consistent pacing signals, helping regulate heart function in patients who require long-term cardiac rhythm management. These electrodes ensure the heart beats at a steady, appropriate rate by delivering timed electrical impulses.
Are the Medtronic Models 4011 & 4511 electrodes intended for reuse, or are they meant for single-use implantation?
The Medtronic Models 4011 & 4511 electrodes are explicitly intended for single-use implantation in a clinical setting. They are supplied sterile and should not be reused, as this could compromise patient safety and device performance.
What regulatory pathway was followed for FDA clearance of these electrodes, and when was the initial clearance granted?
The Medtronic Models 4011 & 4511 electrodes were cleared through the FDA’s 510(k) pathway under the Traditional review process, with a decision of Substantially Equivalent (SESE). The initial clearance was granted on November 30, 1982, following a submission received on September 14, 1982. They are classified as Class III devices under FDA regulations (870.3680).
How should these electrodes be stored, and what precautions should be taken before implantation?
Since the Medtronic Models 4011 & 4511 electrodes are supplied sterile, they must be stored according to the manufacturer’s instructions to maintain sterility until use. Proper storage typically involves keeping them in their original packaging, away from moisture, extreme temperatures, and contamination. Always verify the sterility seal and expiration date before implantation to ensure safety and efficacy.
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: MEDTRONIC MODELS 4011 & 4511 (K822781) - FDA 510 (k), Medtronic Models 4011 4511 - Medtronic Vascular | FDA Evidence Review, MEDTRONIC MODELS 4011 & 4511 (K822781) — FDA 510(k) | Innolitics, PDF K822781 MEDTRONIC MODELS 4011 & 4511 - 510kdatabase.net, Mod Target Tips - Medtronic Vascular | FDA Reference
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K822781 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K822781 24 fields · synced Oct 6, 2026