(24 days)
The AXXESS™ Lead is designed to be utilized as the lead component of a spinal cord stimulation system and is used to aid in the management of chronic pain of the trunk and/or extremities.
The AXXESS™ lead system is designed to be used with the following devices:
- Medtronic® Mattrix® Model 3272 RF system receiver and compatible transmitter, or .
- Medtronic® X-TREL® Model 3470 RF system receiver and compatible transmitter ● using the Medtronic® Model 7495 Quadripolar extension , and
- Medtronic® Model 3550-05 Percutaneous Extension with the Medtronic® Model 3550-. 03 Screener cable, and
- The Medtronic® Model 3628 DualScreen™ Screener using Axxess Screener Cable or ●
- The ANS TS-8 or MNT90T/TR-16 Test Stimulator using Axxess Screener Cable. ●
Axxess Spinal Cord Stimulation Lead, Model 8000 Series
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a spinal cord stimulation lead. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot fulfill your request based on the provided input.
§ 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).