PMA · Approved
Recalled · Class I · 2026Harmony™ TPV System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NPV Pulmonary Valve Prosthesis Percutaneously Delivered
Approved on Mar 26, 2021 through premarket approval, which rests on the device’s own clinical evidence after a 128-day review. It has a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Mar 26, 2021
- Review
- 128 days
- Class
- Class f
- Product code
- NPV
- Recalls
- 2 (2 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P200046 has 51 supplements since 2021: 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 |
|---|---|
| 2021 | 5 |
| 2022 | 8 |
| 2023 | 13 |
| 2024 | 8 |
| 2025 | 9 |
| 2026 | 8 |
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.
1 device in this family has a Class I recall. 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2026 | Class I | Z-2624-2026 | Process control | Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue. |
| Mar 2, 2022 | Class I | Z-0927-2022 | Under Investigation by firm | There is potential for the capsule bond to break during the procedure. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NPV devicesNPV Pulmonary Valve Prosthesis Percutaneously Delivered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NPV
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPV
Too few NPV 510(k)s in any year since 2007 to give a median.
Recalls per year · NPV
1in 2022
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NPV
329in 2025
MAUDE reports naming product code NPV, 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 | 20 |
| 2011 | 0 | — | 0 | 41 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 36 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 72 |
| 2016 | 3 | — | 0 | 66 |
| 2017 | 5 | — | 0 | 96 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 4 | — | 0 | 143 |
| 2020 | 7 | — | 0 | 112 |
| 2021 | 16 | — | 0 | 153 |
| 2022 | 26 | — | 1 (1) | 191 |
| 2023 | 36 | — | 0 | 253 |
| 2024 | 19 | — | 0 | 325 |
| 2025 | 22 | — | 0 | 329 |
| 2026 | 24 | — | 1 (1) | — |
https://510kreport.com/device/P200046 · printed Nov 3, 2026
Cite this page
510(k) Report. “P200046: Harmony™ TPV System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P200046
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026