Identifiers
- 510(k) Number
- K971756 FDA 510(k)
- FDA Product Code
- GZB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5880 FDA 510(k)
- Regulation Number
- 882.5880 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Model 3998 Lead is an implanted spinal cord stimulator lead used in the management of chronic pain of the trunk and limbs. It can serve as the sole mitigating agent or as an adjunct to other modes of therapy in a multidisciplinary approach to chronic pain alleviation. This device is classified as a Stimulator, Spinal-cord, Implanted for Pain Relief.
The Medtronic Model 3998 Lead is supplied by Medtronic Vascular and received FDA 510(k) clearance on February 3, 1998 (K971756). It is a Class II device under product code GZB with special controls. The device is intended for implantation and use in the specified pain management applications, with regulatory authorization documented in the FDA registry.
Frequently asked questions
What is the Medtronic Model 3998 Lead used for?
The Medtronic Model 3998 Lead is an implanted spinal cord stimulator lead designed for managing chronic pain of the trunk and limbs. It can be used as the sole treatment or as part of a multidisciplinary approach to chronic pain alleviation.
How is the Medtronic Model 3998 Lead supplied?
The Medtronic Model 3998 Lead is supplied by Medtronic Vascular. It is a Class II device under product code GZB with special controls, intended for implantation in specified pain management applications.
What is the regulatory status of the Medtronic Model 3998 Lead?
The Medtronic Model 3998 Lead received FDA 510(k) clearance on February 3, 1998 (K971756). It is classified as a Class II device with special controls, and its regulatory authorization is documented in the FDA registry.
Is the Medtronic Model 3998 Lead reusable or single-use?
The device data does not specify whether the Medtronic Model 3998 Lead is reusable or single-use. As an implanted spinal cord stimulator lead, its usage would be determined by the clinical requirements and standard medical practices for such devices.
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 MODEL 3998 LEAD (K971756) — FDA 510(k) | Innolitics, MEDTRONIC MODEL 3998 LEAD by MEDTRONIC VASCULAR | FDA 510(k) Summary, MEDTRONIC MODEL 3998 LEAD (K971756) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971756 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K971756 24 fields · synced Oct 6, 2026