PMA · Approved
ApprovedAttain Starfix Model 4195 Lead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
Approved on Mar 20, 2025 through premarket approval, which rests on the device’s own clinical evidence after a 35-day review.
- Decided
- Mar 20, 2025
- Review
- 35 days
- Class
- Class III
- Product code
- OJX
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
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 OJX? 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OJX devicesOJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OJX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OJX
Too few OJX 510(k)s in any year since 2007 to give a median.
Recalls per year · OJX
No recall names OJX since 2007.
Adverse event reports per year · OJX
3,372in 2025
MAUDE reports naming product code OJX, 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 | 1 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 9 | — | 0 | 66 |
| 2010 | 41 | — | 0 | 1,437 |
| 2011 | 63 | — | 0 | 3,030 |
| 2012 | 47 | — | 0 | 2,417 |
| 2013 | 41 | — | 0 | 2,482 |
| 2014 | 16 | — | 0 | 3,002 |
| 2015 | 11 | — | 0 | 3,724 |
| 2016 | 27 | — | 0 | 3,030 |
| 2017 | 19 | — | 0 | 3,293 |
| 2018 | 24 | — | 0 | 3,978 |
| 2019 | 21 | — | 0 | 3,926 |
| 2020 | 19 | — | 0 | 2,776 |
| 2021 | 19 | — | 0 | 2,869 |
| 2022 | 9 | — | 0 | 2,947 |
| 2023 | 11 | — | 0 | 4,468 |
| 2024 | 7 | — | 0 | 3,395 |
| 2025 | 5 | — | 0 | 3,372 |
| 2026 | 3 | — | 0 | — |
https://510kreport.com/device/P060039/S118 · printed Nov 6, 2026
Cite this page
510(k) Report. “P060039/S118: Attain Starfix Model 4195 Lead.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P060039/S118
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026