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Rebel Platinum Chromium Coronary Stent System (Monorail and Over the Wire)

by Boston Scientific

PMA P130030

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P130030↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP130030 Date10 Mar 2026ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0580-2020 FDA Class II initiated 24 Oct 2019

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
STENT, CORONARY
FDA applicant
Boston Scientific Corp
PMA Number
FDA Product Code
MAF
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Rebel Platinum Chromium Coronary Stent System is a coronary stent indicated for improving coronary luminal diameter in patients with de novo lesions ≤ 28 mm in length in native coronary arteries with a reference vessel diameter (RVD) of ≥ 2.25 to ≥ 4.50 mm. It is designed for percutaneous transluminal coronary angioplasty procedures.

This system is supplied in both Monorail and Over-the-Wire configurations. It is a Class III device authorized under FDA PMA (P130030) and is intended for use in cardiovascular interventional settings by trained physicians.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the maximum lesion length this stent is indicated for?

    The Rebel Platinum Chromium Coronary Stent System is indicated for de novo lesions up to 28 mm in length, as stated in the approval documentation.

  • What reference vessel diameter range is this stent suitable for?

    The stent is indicated for use in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.50 mm, based on the device's approved labeling.

  • Is this stent system available in both Monorail and Over-the-Wire delivery configurations?

    Yes, the Rebel Platinum Chromium Coronary Stent System is supplied in both Monorail and Over-the-Wire configurations, as specified in the trade name and device data.