(107 days)
St. Jude Medical Neuromodulation Division percutaneous trial leads and compatible accessories are indicated for spinal cord stimulation in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach.
OctrodeX™ and QuattrodeX™ trial leads and their accessories are intended to be used during a spinal cord stimulation trial period for a maximum of 30 days.
OctrodeX TM, IntrodeX™, Epidural Needle, Stylets
The provided text is a 510(k) premarket notification approval letter for St. Jude Medical Neuromodulation devices. This document does not contain any information about acceptance criteria, study details, or device performance against such criteria.
The letter confirms that the FDA has determined the devices (OctrodeX™, QuattrodeX™, IntrodeX™, Epidural Needle, Stylets) are substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not provide any clinical study results or performance data.
Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is not present in 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).