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Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), Resume TL Lead Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032561

by Medtronic Vascular

Identifiers

510(k) Number
K032561 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)

This device is a quadripolar implantable neurostimulation lead kit, classified as a spinal-cord stimulator for implanted pain relief. It is designed to deliver electrical stimulation to the spinal cord or peripheral nerves to manage chronic intractable pain in the trunk and limbs. The leads are intended for use in patients requiring spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS) to alleviate severe, treatment-resistant pain.

The Resume II Lead Kit is supplied as a sterile, single-use device intended for surgical implantation by qualified medical professionals. It includes in-line connectors for compatibility with neurostimulation systems and is regulated under FDA 510(k) clearance (K032561) as a Class II device. Storage and handling must adhere to sterile medical device protocols, and its use is restricted to clinical settings where neurostimulation procedures are performed.

Frequently asked questions

What is the Resume II Lead Kit designed to treat?

The Resume II Lead Kit is a quadripolar implantable neurostimulation lead intended for spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS). It delivers electrical impulses to the spinal cord or peripheral nerves to manage chronic, intractable pain in the trunk and limbs when conventional treatments have failed. This approach is particularly suited for patients with severe, persistent pain syndromes that do not respond adequately to other interventions.

How is the Resume II Lead Kit supplied and prepared for use?

The Resume II Lead Kit is supplied as a sterile, single-use device. It is intended exclusively for surgical implantation by qualified medical professionals in clinical settings. The kit includes in-line connectors designed for compatibility with neurostimulation systems, ensuring proper integration with the broader pain management therapy. Sterility is maintained through controlled manufacturing and packaging, adhering to strict medical device protocols.

Is the Resume II Lead Kit reusable or intended for single-use?

The Resume II Lead Kit is explicitly designed for single-use only. After implantation, the lead is intended to remain in the patient’s body permanently as part of the neurostimulation therapy. Reuse of the lead is not permitted due to risks associated with contamination, degradation, or loss of sterility, which could compromise patient safety and device performance.

What storage and handling precautions must be followed for the Resume II Lead Kit?

The Resume II Lead Kit must be stored and handled according to sterile medical device protocols to preserve its integrity and sterility. This includes maintaining the original packaging until immediate preoperative use, protecting it from physical damage, and ensuring it is stored in a clean, controlled environment—such as a sterile processing area or operating room—where contamination risks are minimized. Improper storage could invalidate sterility and compromise surgical outcomes.

What regulatory pathway does the Resume II Lead Kit follow?

The Resume II Lead Kit is regulated under the FDA’s 510(k) clearance process, specifically classified as a Class II device with a clearance number (K032561). This pathway confirms that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for spinal-cord stimulators intended for implanted pain relief. The clearance was granted by the FDA’s Neurology Advisory Committee.

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: Resume Ii Lead Kit for Spinal Cord Stimulation (Scs) and Peripheral ..., PDF Resume Ii Lead Kit for Spinal Cord Stimulation (Scs) and Peripheral ..., RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS)… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K032561 24 fields · synced Oct 5, 2026