(94 days)
The ANS Axxess™ Percutaneous Leads (41XX Series) are designed to be utilized as the lead component of spinal cord stimulation systems and is used to aid in the management of chronic pain of the trunk and/or extremities.
The ANS Axxess™ Percutaneous Lead system is designed to be used with the following devices:
ANS Renew Receiver (34XX series) and Transmitter (35XX series) ANS Lead Extension Models 3341, 3342, 3343, and 3346
ANS Axxess™ Percutaneous Lead, Models 4143, 4146, 4153 and 4156
This document is a marketing clearance letter from the FDA for a medical device called "ANS Axxess Percutaneous Lead". It does not contain any information regarding acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot provide the requested information based on the input document.
§ 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).