Rebel™ H7493927416350
Rebel™ H7493927416350 is a Class III device made by Boston Scientific, approved under FDA PMA P130030 on 10 Mar 2026 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 08714729843795), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
PMA
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP130030 | Date10 Mar 2026 | StatusActive |
| United States | GUDID listing | Number08714729843795 | Date24 Sep 2014 | StatusListed |
Official records
- AccessGUDID record 08714729843795
- FDA PMA database P130030
Across registries
- FDA PMA P130030 decided 10 Mar 2026 Active
- FDA GUDID UDI-DI 08714729843795 listed 24 Sep 2014 Listed
Recalls
-
- Terminated 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 manufacturing process.
Timeline
- Listed FDA GUDID 08714729843795
- Recall initiated FDA recalls Z-0580-2020
- Approved FDA PMA P130030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Rebel™
- Generic name
- Bare-metal coronary artery stent
- Model / Ref / Catalog
- H7493927416350
- Primary DI / UDI-DI
- 08714729843795
- PMA number
- FDA product code
- MAF
- GMDN term
- Bare-metal coronary artery stent
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional