510(k) Report

FDA applicant

Medtronic Neuromodulation

Minneapolis5 decisions1984–202514 recalls

FDA records 5 decisions for Medtronic Neuromodulation (Minneapolis) from 1984 to 2025: 1 De Novo grant and 4 original PMA approvals. Most are in product codes EZW (Stimulator, Electrical, Implantable, For…) and QPT (Stimulator, Tibial, Electrical, Implantable…). 14 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Medtronic Neuromodulation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2011: 12021: 12025: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007: 22013: 12014: 12015: 12016: 12021: 12022: 12023: 22024: 22025: 1
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Neuromodulation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EZWStimulator, Electrical, Implantable, For Incontinence1decision
  • QPTStimulator, Tibial, Electrical, Implantable, For Urinary Incontinence1decision
  • QQCBrain Stimulation Programming Planning Software.1decision
  • LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief1decision
  • QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN210003SureTune4 SoftwareMedtronic Neuromodulation · 20212cite it
  • P970004Medtronic Interstim Therapy System for Urinary ControlMedtronic Neuromodulation · 19971cites it

What has FDA decided for it lately?

  • P240011Medtronic Altaviva SystemMedtronic Neuromodulation · 2025
  • DEN210003SureTune4 SoftwareMedtronic Neuromodulation · 2021
  • P080025Medtronic Interstim Sacral Nerve Stimulation Therapy SystemMedtronic Neuromodulation · 20115 recalls
  • P970004Medtronic Interstim Therapy System for Urinary ControlMedtronic Neuromodulation · 19975 recalls
  • P840001Itrel (R) Totally Implantable Spinal Cord Stim. SysMedtronic Neuromodulation · 19849 recalls

All 5 as Medtronic Neuromodulation →

What has been recalled?

14 recalls linked to its devices; the latest:

  • P080025Enhanced Verify Evaluation Handset (CFN HH90130FA)Apr 3, 2025Class II
  • P840001Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and…Sep 18, 2024Class II
  • P840001Intellis AdaptiveStim Product Number 97715, Spinal Cord StimulatorMar 28, 2024Class II
  • P840001Model A710 Intellis Clinician Programmer Application, version 2.0.97Dec 19, 2023Class II
  • P070004S001Medtronic InterStim Ground Pad REF 041826Jul 6, 2023Class II
  • P080025MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a)…Feb 28, 2022Class II