← Product Code [GZF](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF) · K960631

# MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX (K960631)

_Medtronic Vascular · GZF · May 21, 1996 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K960631

## Device Facts

- **Applicant:** Medtronic Vascular
- **Product Code:** [GZF](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF.md)
- **Decision Date:** May 21, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5870
- **Device Class:** Class 2
- **Review Panel:** Neurology
- **Attributes:** Therapeutic

## Indications for Use

Medtronic considers nonsterile packaging of spinal cord and peripheral nerve stimulation lead accessories with appropriate labeling and instructions for sterilization by the user to be substantially equivalent in design, function, materials, and intended use to previous accessory devices.

## Device Story

Accessories for spinal cord and peripheral nerve stimulation leads; provided in nonsterile packaging; intended for user-performed sterilization; supplied as kits, piece parts, or bulk; labeling includes sterilization instructions; used by clinicians in surgical or clinical settings to facilitate lead placement or connection; ensures compatibility with existing stimulation systems.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Spinal cord and peripheral nerve stimulation lead accessories; nonsterile packaging; materials consistent with previous predicate accessory devices; requires user-performed sterilization.

## Regulatory Identification

An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

K960631

February 12, 1996

MAY 21 1996

RE: 510(k) Notification: Medtronic Model 3550 Accessories

In order to comply with the Safe Medical Devices Act of 1990, this one page will provide safety and effectiveness information to interested persons.

SUMMARY OF SAFETY AND EFFECTIVENESS

Medtronic considers nonsterile packaging of spinal cord and peripheral nerve stimulation lead accessories with appropriate labeling and instructions for sterilization by the user to be substantially equivalent in design, function, materials, and intended use to previous accessory devices. Packaging of the nonsterile accessories will be either in kits, as separate piece parts or in bulk packaging that in no way resembles sterile packaging. The word "Nonsterile" will be obviously displayed on the packaging and instructions for sterilization will be included in the labeling.

Sincerely,

MEDTRONIC, INC.
Neurological Business

![img-0.jpeg](img-0.jpeg)

Jean Prather
Senior Clinical Research Associate

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K960631](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K960631)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com