# P130030: Rebel Platinum Chromium Coronary Stent System Monorail and Over the Wire

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Mar 10, 2026 after 4,453 days
- Product code: MAF (Stent, Coronary)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 24, 2019 · Class II · Z-0580-2020: 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 manufact

Source page: https://510kreport.com/device/P130030
Methodology: https://510kreport.com/methodology