PMA · Approved
ApprovedEDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · LWR Heart-Valve, Non-Allograft Tissue
Approved on Jun 29, 2017 through premarket approval, which rests on the device’s own clinical evidence after a 549-day review.
- Decided
- Jun 29, 2017
- Review
- 549 days
- Class
- Class III
- Product code
- LWR
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P150048 has 97 supplements since 2017: 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 |
|---|---|
| 2017 | 6 |
| 2018 | 23 |
| 2019 | 10 |
| 2020 | 9 |
| 2021 | 7 |
| 2022 | 12 |
| 2023 | 6 |
| 2024 | 10 |
| 2025 | 6 |
| 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.
Planning a device in LWR? 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 LWR devicesLWR Heart-Valve, Non-Allograft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LWR
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWR
Too few LWR 510(k)s in any year since 2007 to give a median.
Recalls per year · LWR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWR
1,866in 2025
MAUDE reports naming product code LWR, 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 | 8 | — | 0 | 703 |
| 2008 | 7 | — | 0 | 1,552 |
| 2009 | 15 | — | 0 | 376 |
| 2010 | 17 | — | 0 | 279 |
| 2011 | 25 | — | 0 | 258 |
| 2012 | 18 | — | 0 | 718 |
| 2013 | 31 | — | 0 | 326 |
| 2014 | 27 | — | 1 | 365 |
| 2015 | 14 | — | 0 | 525 |
| 2016 | 27 | — | 1 | 736 |
| 2017 | 54 | — | 0 | 1,367 |
| 2018 | 64 | — | 0 | 1,593 |
| 2019 | 50 | — | 0 | 1,855 |
| 2020 | 32 | — | 0 | 1,437 |
| 2021 | 18 | — | 0 | 1,550 |
| 2022 | 37 | — | 0 | 1,084 |
| 2023 | 26 | — | 0 | 1,592 |
| 2024 | 27 | — | 0 | 1,829 |
| 2025 | 27 | — | 0 | 1,866 |
| 2026 | 19 | — | 0 | — |
https://510kreport.com/device/P150048 · printed Nov 6, 2026
Cite this page
510(k) Report. “P150048: EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P150048
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026