# K032751: Modification to Renew Lead Extension

- Pathway: 510(k) (Special)
- Applicant: Advanced Neuromodulation Systems
- Decided: Oct 6, 2003 after 31 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
ANS Renew Lead Extensions are indicated for the treatment 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. Lead Extensions are intended to be used with Advanced Neuromodulation Systems’, leads, receivers, transmitters, and antennae.

Source page: https://510kreport.com/device/K032751
Methodology: https://510kreport.com/methodology