PMA · Approved
Recalled · Class II · 2025Medtronic Micra Transcatheter Pacemaker System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · PNJ Leadless Pacemaker
Approved on Apr 6, 2016 through premarket approval, which rests on the device’s own clinical evidence after a 202-day review. It has been recalled 4 times.
- Decided
- Apr 6, 2016
- Review
- 202 days
- Class
- Class III
- Product code
- PNJ
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P150033 has 225 supplements since 2016: 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 |
|---|---|
| 2016 | 11 |
| 2017 | 17 |
| 2018 | 18 |
| 2019 | 15 |
| 2020 | 27 |
| 2021 | 37 |
| 2022 | 33 |
| 2023 | 20 |
| 2024 | 14 |
| 2025 | 22 |
| 2026 | 11 |
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 PNJ? 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 |
|---|---|---|---|---|
| Jun 17, 2025 | Class II | Z-2128-2025 | Software design | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device… |
| Jun 17, 2025 | Class II | Z-2127-2025 | Software design | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device… |
| Aug 6, 2019 | Class II | Z-2492-2019 | Other | Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant. |
| Aug 6, 2019 | Class II | Z-2493-2019 | Other | Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All PNJ devicesPNJ Leadless Pacemaker: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PNJ
33in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNJ
Too few PNJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PNJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PNJ
4,379in 2025
MAUDE reports naming product code PNJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 12 | — | 0 | 84 |
| 2017 | 17 | — | 0 | 290 |
| 2018 | 18 | — | 0 | 656 |
| 2019 | 15 | — | 0 | 837 |
| 2020 | 27 | — | 0 | 1,148 |
| 2021 | 37 | — | 0 | 1,479 |
| 2022 | 36 | — | 0 | 1,712 |
| 2023 | 22 | — | 0 | 2,626 |
| 2024 | 28 | — | 1 | 3,392 |
| 2025 | 33 | — | 0 | 4,379 |
| 2026 | 21 | — | 1 | — |
https://510kreport.com/device/P150033 · printed Nov 6, 2026
Cite this page
510(k) Report. “P150033: Medtronic Micra Transcatheter Pacemaker System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P150033
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026