# K971756: Medtronic Model 3998 Lead

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Feb 3, 1998 after 267 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic® Model 3586 Resume® Lead: named in the summary without a submission number
- (no number) Medtronic® Model 3587A Resume II® Lead: named in the summary without a submission number
- (no number) Medtronic® Model 3982 SymMix® Lead: named in the summary without a submission number
- (no number) Medtronic® Model 3983 Lead: named in the summary without a submission number
- (no number) Medtronic® Model 3993 TTL Lead: named in the summary without a submission number
- (no number) Medtronic® Model 3483S Pisces-Sigma® Lead: named in the summary without a submission number

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

## Recalls of this device
- May 21, 2008 · Not classified · Z-2241-2008: Medtronic is recalling certain lots of Model 3998 SPECIFY surgical lead kits due to a package mislabeling issue. The package labeling incorrectly states the lead length is 28 cm in length when it shou

## Indications for use
The Medtronic® Model 3998 Specify™ Lead is indicated in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjungt to other modes of therapy used in a multidisciplinary approach to chronic pain alleviation.

Source page: https://510kreport.com/device/K971756
Methodology: https://510kreport.com/methodology