PMA · Approved
Recalled · Class II · 2019Rebel Platinum Chromium Coronary Stent System Monorail and Over the Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MAF Stent, Coronary
Approved on Mar 10, 2026 through premarket approval, which rests on the device’s own clinical evidence after a 4,453-day review. It has been recalled once.
- Decided
- Mar 10, 2026
- Review
- 4,453 days
- Class
- Class III
- Product code
- MAF
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P130030 has 75 supplements since 2014: 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 |
|---|---|
| 2014 | 6 |
| 2015 | 9 |
| 2016 | 16 |
| 2017 | 14 |
| 2018 | 10 |
| 2019 | 7 |
| 2020 | 7 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 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 MAF? 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 |
|---|---|---|---|---|
| Oct 24, 2019 | Class II | Z-0580-2020 | Process control | Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MAF devicesMAF Stent, Coronary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MAF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAF
Too few MAF 510(k)s in any year since 2007 to give a median.
Recalls per year · MAF
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAF
111in 2025
MAUDE reports naming product code MAF, 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 | 34 | — | 1 | 1,201 |
| 2008 | 41 | — | 1 | 1,288 |
| 2009 | 36 | — | 5 | 1,370 |
| 2010 | 55 | — | 0 | 1,568 |
| 2011 | 67 | — | 0 | 1,233 |
| 2012 | 77 | — | 0 | 1,053 |
| 2013 | 41 | — | 0 | 1,049 |
| 2014 | 53 | — | 0 | 876 |
| 2015 | 22 | — | 0 | 664 |
| 2016 | 26 | — | 0 | 696 |
| 2017 | 35 | — | 0 | 695 |
| 2018 | 32 | — | 0 | 675 |
| 2019 | 25 | — | 1 | 561 |
| 2020 | 21 | — | 0 | 430 |
| 2021 | 13 | — | 0 | 329 |
| 2022 | 8 | — | 0 | 280 |
| 2023 | 8 | — | 0 | 207 |
| 2024 | 3 | — | 0 | 219 |
| 2025 | 2 | — | 0 | 111 |
| 2026 | 4 | — | 0 | — |
https://510kreport.com/device/P130030 · printed Nov 4, 2026
Cite this page
510(k) Report. “P130030: Rebel Platinum Chromium Coronary Stent System Monorail and Over the Wire.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P130030
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026