MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION

• K Number: K010300
• Device Name: MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
• Manufacturer: MEDTRONIC VASCULAR
• Date Cleared: 2001-08-01 ( 181 days)
• Product Code: GZB
• Regulation Number: 882.5880

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 882.5880 Implanted spinal cord stimulator for pain relief.

(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).

Summary

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