# K964172: Medtronic Model 3991A, 3992A, 3993A, 3994A Leads or Transverse Tripolar Leads or TTL

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jul 3, 1997 after 258 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 K884948 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913993: Medtronic Models 3982 a,B,C&D Stag Array Res Leads, Medtronic Vascular (1992) Summary page 1.
- K952459: Medtronic Model 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C Leads or, Transverse Tripolar Leads or, TTL, Medtronic Vascular (1995) Summary page 1.
- K923931: Medtronic Model 3487A Pisces-Quad Lead, Medtronic Vascular (1993) Summary page 1.
- K910199: Medtronic Model 3487A Pisces-Quad Lead, Medtronic Vascular (1991) Summary page 1.
- K923567: Medtronic Model 3888 Pisces-Quad Plus Lead, Medtronic Vascular (1992) Summary page 1.
- K884948: Model 3587A Resume Epidural Lead, Medtronic Vascular (1989) Summary page 1.

## Indications for use
Model 3991 A Series Leads are indicated for use for epidural spinal cord stimulation (SCS) as an aid in the treatment of chronic intractable pain of the trunk and/or limbs. All other uses are considered investigational.

Source page: https://510kreport.com/device/K964172
Methodology: https://510kreport.com/methodology