MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX
Device Facts
| Record ID | K960631 |
|---|---|
| Device Name | MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX |
| Applicant | Medtronic Vascular |
| Product Code | GZF · Neurology |
| Decision Date | May 21, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5870 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Indications for Use
Indicated for patients requiring spinal cord or peripheral nerve stimulation therapy; accessories used in conjunction with stimulation leads.
Regulatory Classification
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.
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