# K040568: Polyether Urethane Material Change in Neurostimulation Leads

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Mar 25, 2004 after 21 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 K905407 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923931: Medtronic Model 3487A Pisces-Quad Lead, Medtronic Vascular (1993) Summary page 2.
- K923567: Medtronic Model 3888 Pisces-Quad Plus Lead, Medtronic Vascular (1992) Summary page 2.
- K033016: Pisces Z Quad Lead Model, 3890, Pisces Z Quad Compact Lead Model, 3891, Pisces Z Quad Plus Lead Model, 3892, Medtronic Neurological (2003) Summary page 2.
- K971756: Medtronic Model 3998 Lead, Medtronic Vascular (1998) Summary page 2.
- K934065: Medtronic Mattrix 3271/3272 Neurostimulation System, Medtronic Vascular (1995) Summary page 2.
- K032561: Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), Resume TL Lead Kit for, Medtronic Vascular (2003) Summary page 2.
- K912764: Medtronic Model 3861 Temporary Screening Lead Kit, Medtronic Vascular (1991) Summary page 2.
- K932202: Model 3862A & B 3863A & B Temp. Lead Screening Kit, Medtronic Vascular (1994) Summary page 2.

## Indications for use
Pisces Quad Model 3487A, Pisces Quad Compact Model 3887, Pisces Quad Plus Model 3888, Pisces Z Quad Model 3890, Pisces Z Quad Compact Model 3891, Pisces Z Quad Plus Model 3892, Specify Model 3998, Pisces Octad Model 3898, SymMix Model 3982A, Temporary Screening Lead Model 3861, and Verify Model 3862 are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. Resume II Model 3587A and Resume TL Model 3986A are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. They are also indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain. On-Point Model 3987A is indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

Source page: https://510kreport.com/device/K040568
Methodology: https://510kreport.com/methodology