# K030461: A127 Lead Extension

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Neuromodulation Systems
- Decided: Apr 24, 2003 after 71 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 ANSO A127 Lead Extension is designed to be utilized as the lead extension component of a spinal cord stimulation system (SCS) and is indicated for spinal cord stimulation in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The A127 Lead Extension Models 2341, 2342, 2343 and 2346 are designed to be used with the following devices: Micronet Axxess™ Lead Model 8000, 8100 and 8200 series Medtronic Pisces Quad® Lead Model 3487 Medtronic Pisces Quad® Plus Lead Model 3888 Medtronic Pisces Quad® Compact Lead Model 3887 Medtronic Specify™ Lead Model 3998 Medtronic Resume® II Lead Model 3587A ANS Renew® Receiver Model 3408 ANS Renew® Transmitter Model 3508

Source page: https://510kreport.com/device/K030461
Methodology: https://510kreport.com/methodology