(24 days)
Advanced Neuromodulation Systems 90 cm and 110 cm (3100 and 3200 Series) Leads are indicated for the management of chronic pain of the trunk and/or limbs either as the sole mitigating agent, or as an adjunct to other modes of therapy as part of a multidisciplinary approach and are intended for use with Advanced Neuromodulation Systems receivers, IPGs, transmitters, and/or antennae.
Not Found
This document, K053250, is a 510(k) premarket notification letter from the FDA regarding the ANS 3100 and 3200 series leads. It is primarily an approval letter and an "Indications For Use" statement. It does not contain any information about acceptance criteria, study details, or device performance data.
Therefore, I cannot provide the requested information based on this document. To answer your questions, I would need access to the actual 510(k) submission or supporting clinical study reports for the device.
§ 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).