# K032561: Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), Resume TL Lead Kit for

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Sep 11, 2003 after 22 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: 1 generation back to K905407 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905407: Model 3487A Pisces-Quad,3587A Resume,3586 Resume, Medtronic Vascular (1991). Our reading of the summary gave K904507, FDA’s number for Pilling Brush Valvulotome (Pilling Co.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Resume I1 3587A”.
- K913993: Medtronic Models 3982 a,B,C&D Stag Array Res Leads, Medtronic Vascular (1992) Summary page 1.
- K920567: Models 3987 and 3988 Resume Lead for PNS, Medtronic Vascular (1992) Summary page 1.

## Most influential descendants
- K040568: Polyether Urethane Material Change in Neurostimulation Leads (2004), 0 descendants of its own

## Indications for use
Resume 11 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. SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.

Source page: https://510kreport.com/device/K032561
Methodology: https://510kreport.com/methodology