PMA · Approved
ApprovedSweet Tip (R) RX Steroid Eluting Lead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
Approved on Oct 2, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 942-day review.
- Decided
- Oct 2, 1998
- Review
- 942 days
- Class
- Class III
- Product code
- NVN
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P960006 has 52 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 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 4 |
| 2005 | 5 |
| 2006 | 2 |
| 2007 | 1 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 6 |
| 2013 | 3 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 5 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 2 |
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 NVN? 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 NVN devicesNVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/P960006 · printed Nov 6, 2026
Cite this page
510(k) Report. “P960006: Sweet Tip (R) RX Steroid Eluting Lead.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960006
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026