# K990469: Lamitrode Leads

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Neuromodulation Systems
- Decided: Jun 3, 1999 after 107 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
Longest line of descent: 2 generations back to K810182 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853643: Multistim Laminectomy Electrode, Neuromed, Inc. (1985) Summary page 2.
- K905255: Neuromed Model 1992 LS Lamitrode Lead, Neuromed, Inc. (1991) Summary page 2.
- K960728: One Step Connect Leads (Quattrode, Octrode, Cervitrode), Neuromed, Inc. (1996) Summary page 2.
- K884948: Model 3587A Resume Epidural Lead, Medtronic Vascular (1989) Summary page 3.
- K811655: Myelostat Dorsal Cord Stimulator, Medtronic Vascular (1981) Summary page 3.
- K905407: Model 3487A Pisces-Quad,3587A Resume,3586 Resume, Medtronic Vascular (1991) Summary page 3.

## Indications for use
Advanced Neuromodulation Systems Lamitrode Spinal Cord Stimulation Leads 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 and is intended to be used with Advanced Neuromodulation Systems extensions and/or receivers, transmitters, and antennae. The proposed device modification does not affect the original intended use of the legally marketed device.

Source page: https://510kreport.com/device/K990469
Methodology: https://510kreport.com/methodology