# K030674: Modification to Axxess Spinal Cord Stimulation Lead

- Pathway: 510(k) (Special)
- Applicant: Advanced Neuromodulation Systems
- Decided: Mar 28, 2003 after 24 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AXXESSTM 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 AXXESSTM lead system is designed to be used with the following devices: • MedtronicB MattrixB Model 3272 RF system receiver and compatible transmitter, or • MedtronicB X-TRELB Model 3470 RF system receiver and compatible transmitter using the MedtronicB Model 7495 Quadripolar extension, and • MedtronicB Model 3550-05 Percutaneous Extension with the MedtronicB Model 3550-03 Screener cable, and • The MedtronicB Model 3628 DualScreenTMScreener using Axxess Screener Cable or • The ANS TS-8 or MNT90TRR-16 Test Stimulator using Axxess Screener Cable.

Source page: https://510kreport.com/device/K030674
Methodology: https://510kreport.com/methodology