FDA product code · Cardiovascular
Pulse Generator, Permanent, Implantable
5 FDA decisions since 1989. 25 recalls name this code, 7 of them Class I. The most-cited predicate is P890003, named by 1 later device.
Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in 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 NVZ 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 · NVZ
39in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVZ
Too few NVZ 510(k)s in any year since 2007 to give a median.
Recalls per year · NVZ
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · NVZ
5,970in 2025
MAUDE reports naming product code NVZ, 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 | 124 | — | 2 | 85 |
| 2008 | 164 | — | 1 | 142 |
| 2009 | 124 | — | 4 | 245 |
| 2010 | 181 | — | 1 | 4,039 |
| 2011 | 178 | — | 1 | 6,334 |
| 2012 | 130 | — | 0 | 5,562 |
| 2013 | 131 | — | 0 | 4,033 |
| 2014 | 122 | — | 1 | 3,107 |
| 2015 | 88 | — | 0 | 2,773 |
| 2016 | 76 | — | 0 | 2,558 |
| 2017 | 61 | — | 2 | 3,164 |
| 2018 | 59 | — | 0 | 5,878 |
| 2019 | 60 | — | 7 (7) | 8,188 |
| 2020 | 73 | — | 0 | 8,337 |
| 2021 | 40 | — | 1 | 8,538 |
| 2022 | 44 | — | 0 | 7,791 |
| 2023 | 39 | — | 0 | 8,463 |
| 2024 | 42 | — | 2 | 6,496 |
| 2025 | 39 | — | 0 | 5,970 |
| 2026 | 24 | — | 3 | — |
Planning a device in NVZ? 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