PMA · Approved
ApprovedCobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Cardiac Rhythm Disease Management · LWS Implantable Cardioverter Defibrillator (Non-Crt)
Approved on Oct 5, 2026 through premarket approval, which rests on the device’s own clinical evidence after a 24-day review.
- Decided
- Oct 5, 2026
- Review
- 24 days
- Class
- Class III
- Product code
- LWS
- 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 LWS? 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 LWS devicesLWS Implantable Cardioverter Defibrillator (Non-Crt): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LWS
97in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWS
Too few LWS 510(k)s in any year since 2007 to give a median.
Recalls per year · LWS
2in 2025
Class I (12 since 2007) Class II/III not classified
Adverse event reports per year · LWS
24,303in 2025
MAUDE reports naming product code LWS, 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 | 70 | — | 4 | 10,330 |
| 2008 | 94 | — | 3 | 11,327 |
| 2009 | 80 | — | 8 | 13,768 |
| 2010 | 119 | — | 6 | 17,321 |
| 2011 | 136 | — | 8 | 15,097 |
| 2012 | 129 | — | 5 | 12,820 |
| 2013 | 148 | — | 1 | 17,242 |
| 2014 | 168 | — | 0 | 18,594 |
| 2015 | 100 | — | 2 (1) | 14,040 |
| 2016 | 145 | — | 2 (2) | 16,638 |
| 2017 | 162 | — | 7 (5) | 18,454 |
| 2018 | 142 | — | 1 | 17,228 |
| 2019 | 98 | — | 0 | 16,184 |
| 2020 | 125 | — | 6 (3) | 16,909 |
| 2021 | 111 | — | 0 | 19,654 |
| 2022 | 91 | — | 3 | 23,454 |
| 2023 | 101 | — | 2 | 28,701 |
| 2024 | 108 | — | 0 | 25,202 |
| 2025 | 97 | — | 2 (1) | 24,303 |
| 2026 | 93 | — | 0 | — |
https://510kreport.com/device/P980016/S966 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980016/S966: Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980016/S966
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Record history
- FDA decision record loaded Oct 30, 2026
- Page last updated Nov 3, 2026