Medtronic Neuromodulation: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Medtronic Neuromodulation”, plus 4 PMA and 1 De Novo decisions, across 5 product codes in 2 review panels. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EZW | Stimulator, Electrical, Implantable, For Incontinence | 1 | 0 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | 1 | 0 |
| QON | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | 1 | 0 |
| QPT | Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence | 1 | 0 |
| QQC | Brain Stimulation Programming Planning Software. | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240011 | PMA | Medtronic Altaviva System | 2025-09-18 |
| DEN210003 | De Novo | Brain Stimulation Programming Planning Software. | 2021-08-23 |
| P080025 | PMA | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM | 2011-03-14 |
| P970004 | PMA | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL | 1997-09-29 |
| P840001 | PMA | ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS | 1984-11-30 |
Recalls
176 product recalls in 102 recall events; 45 initiated in the last five years. Most recent: 2026-05-13.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medtronic Neuromodulation (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via EZW)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Navigation, Inc. (44 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Neuromodulation?
FDA lists 0 510(k) clearances under the applicant name “Medtronic Neuromodulation”, plus 4 PMA and 1 De Novo decisions, across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Medtronic Neuromodulation?
The most frequent FDA product codes under this applicant name are EZW (Stimulator, Electrical, Implantable, For Incontinence, 1); LGW (Stimulator, Spinal-Cord, Totally Implanted For Pain Relief, 1); QON (Implanted Electrical Device Intended For Treatment Of Fecal Incontinence, 1).
Next steps
- See all 0 Medtronic Neuromodulation clearances with predicates and recalls
- Run predicate analysis for product code EZW, Medtronic Neuromodulation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.