PMA · Approved
Recalled · Class II · 2017Innova Vascular Self-Expanding Stent with Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · NIP Stent, Superficial Femoral Artery
Approved on Jul 21, 2015 through premarket approval, which rests on the device’s own clinical evidence after a 223-day review. It has been recalled 2 times.
- Decided
- Jul 21, 2015
- Review
- 223 days
- Class
- Class III
- Product code
- NIP
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P140028 has 86 supplements since 2015: 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 |
|---|---|
| 2015 | 6 |
| 2016 | 16 |
| 2017 | 8 |
| 2018 | 4 |
| 2019 | 17 |
| 2020 | 14 |
| 2021 | 6 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 2 |
| 2026 | 3 |
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 NIP? 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 |
|---|---|---|---|---|
| Nov 6, 2017 | Class II | Z-0685-2018 | Nonconforming Material/Component | Stent possibly unable to be fully released from the delivery system. |
| Nov 6, 2017 | Class II | Z-0686-2018 | Nonconforming Material/Component | Stent possibly unable to be fully released from the delivery system. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NIP devicesNIP Stent, Superficial Femoral Artery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NIP
34in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIP
Too few NIP 510(k)s in any year since 2007 to give a median.
Recalls per year · NIP
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NIP
837in 2025
MAUDE reports naming product code NIP, 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 | 5 | — | 0 | 32 |
| 2008 | 4 | — | 2 | 87 |
| 2009 | 21 | — | 0 | 152 |
| 2010 | 19 | — | 0 | 119 |
| 2011 | 17 | — | 72 | 119 |
| 2012 | 16 | — | 0 | 211 |
| 2013 | 21 | — | 1 (1) | 250 |
| 2014 | 42 | — | 0 | 403 |
| 2015 | 40 | — | 0 | 600 |
| 2016 | 50 | — | 1 | 846 |
| 2017 | 34 | — | 3 | 789 |
| 2018 | 56 | — | 0 | 546 |
| 2019 | 46 | — | 1 | 717 |
| 2020 | 33 | — | 0 | 802 |
| 2021 | 26 | — | 0 | 837 |
| 2022 | 26 | — | 0 | 831 |
| 2023 | 27 | — | 1 | 875 |
| 2024 | 29 | — | 0 | 1,013 |
| 2025 | 34 | — | 0 | 837 |
| 2026 | 24 | — | 0 | — |
https://510kreport.com/device/P140028 · printed Nov 4, 2026
Cite this page
510(k) Report. “P140028: Innova Vascular Self-Expanding Stent with Delivery System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P140028
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026