FDA product code · Cardiovascular
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
12 FDA decisions since 1986. No recall names this code. The most-cited predicate is P960013, named by 2 later devices.
Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NVN 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 · NVN
36in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVN
Too few NVN 510(k)s in any year since 2007 to give a median.
Recalls per year · NVN
No recall names NVN since 2007.
Adverse event reports per year · NVN
23,350in 2025
MAUDE reports naming product code NVN, 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 | 46 |
| 2008 | 1 | — | 0 | 64 |
| 2009 | 10 | — | 0 | 85 |
| 2010 | 10 | — | 0 | 1,853 |
| 2011 | 11 | — | 0 | 6,196 |
| 2012 | 19 | — | 0 | 5,889 |
| 2013 | 7 | — | 0 | 7,653 |
| 2014 | 5 | — | 0 | 9,886 |
| 2015 | 10 | — | 0 | 10,137 |
| 2016 | 62 | — | 0 | 9,393 |
| 2017 | 67 | — | 0 | 11,613 |
| 2018 | 86 | — | 0 | 11,519 |
| 2019 | 56 | — | 0 | 16,873 |
| 2020 | 69 | — | 0 | 16,529 |
| 2021 | 60 | — | 0 | 17,757 |
| 2022 | 43 | — | 0 | 18,200 |
| 2023 | 38 | — | 0 | 24,991 |
| 2024 | 36 | — | 0 | 22,013 |
| 2025 | 36 | — | 0 | 23,350 |
| 2026 | 35 | — | 0 | — |
Planning a device in NVN? 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