# K022222: Lamitrode S-Series (S4 and S8) Leads

- Pathway: 510(k) (Special)
- Applicant: Advanced Neuromodulation System,Inc
- Decided: Aug 8, 2002 after 30 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 Lamitrode S-Series (S4 and S8) Leads, models 3243, 3246, 3283 and 3286, 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. Lamitrode S4 and S8 leads are design to be connected to ANS neurostimulation receiver, Models 3408 and 3416, transmitter models 3508 and 3516 and extension models 3341, 3342, 3343, 3346, 3382, 3383 and 3386.

Source page: https://510kreport.com/device/K022222
Methodology: https://510kreport.com/methodology