PMA · Approved
Recalled · 2026OmniaSecure™ MRI SureScan™ Lead Model 3930M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NVY Permanent Defibrillator Electrodes
Approved on Apr 22, 2025 through premarket approval, which rests on the device’s own clinical evidence after a 186-day review. It has been recalled once.
- Decided
- Apr 22, 2025
- Review
- 186 days
- Class
- Class III
- Product code
- NVY
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P240036 has 7 supplements since 2025: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2025 | 3 |
| 2026 | 4 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NVY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2026 | Not classified | Z-0285-2027 | Process design | Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NVY devicesNVY Permanent Defibrillator Electrodes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NVY
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVY
Too few NVY 510(k)s in any year since 2007 to give a median.
Recalls per year · NVY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVY
11,513in 2025
MAUDE reports naming product code NVY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | — | 0 | 48 |
| 2008 | 27 | — | 0 | 63 |
| 2009 | 30 | — | 0 | 103 |
| 2010 | 82 | — | 0 | 1,796 |
| 2011 | 89 | — | 0 | 6,003 |
| 2012 | 92 | — | 0 | 8,520 |
| 2013 | 96 | — | 0 | 7,224 |
| 2014 | 86 | — | 0 | 9,530 |
| 2015 | 52 | — | 0 | 8,840 |
| 2016 | 39 | — | 0 | 8,567 |
| 2017 | 14 | — | 0 | 8,452 |
| 2018 | 20 | — | 0 | 8,322 |
| 2019 | 15 | — | 0 | 8,324 |
| 2020 | 13 | — | 0 | 8,020 |
| 2021 | 12 | — | 1 | 8,059 |
| 2022 | 10 | — | 2 | 7,636 |
| 2023 | 12 | — | 0 | 10,442 |
| 2024 | 12 | — | 0 | 9,362 |
| 2025 | 9 | — | 0 | 11,513 |
| 2026 | 10 | — | 1 | — |
https://510kreport.com/device/P240036 · printed Nov 6, 2026
Cite this page
510(k) Report. “P240036: OmniaSecure™ MRI SureScan™ Lead Model 3930M.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P240036
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026