FDA product code · Cardiovascular
Absorbable Coronary Drug-Eluting Stent
1 FDA decision since 2016. No recall names this code.
An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PNY at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PNY
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PNY
Too few PNY 510(k)s in any year since 2007 to give a median.
Recalls per year · PNY
No recall names PNY since 2007.
Adverse event reports per year · PNY
16in 2025
MAUDE reports naming product code PNY, 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 | 5 | — | 0 | 224 |
| 2017 | 4 | — | 0 | 328 |
| 2018 | 1 | — | 0 | 105 |
| 2019 | 0 | — | 0 | 38 |
| 2020 | 0 | — | 0 | 168 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
Planning a device in PNY? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report