PMA · Approved
Recalled · 2009Medtronic.Kappa 400 Series Pacemakers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NVZ Pulse Generator, Permanent, Implantable
Approved on Jan 30, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 357-day review. It has been recalled once.
- Decided
- Jan 30, 1998
- Review
- 357 days
- Class
- Class III
- Product code
- NVZ
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P970012 has 96 supplements since 1998: 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 |
|---|---|
| 1998 | 5 |
| 1999 | 2 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 8 |
| 2007 | 5 |
| 2008 | 13 |
| 2009 | 13 |
| 2010 | 20 |
| 2011 | 11 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 2 |
| 2025 | 1 |
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 NVZ? 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2009 | Not classified | Z-1515-2009 | Device Design | One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NVZ devicesNVZ Pulse Generator, Permanent, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/P970012 · printed Nov 5, 2026
Cite this page
510(k) Report. “P970012: Medtronic.Kappa 400 Series Pacemakers.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P970012
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026