Rebel Platinum Chromium Coronary Stent System Monorail and Over the Wire

FDA premarket approval P130030 · Stent, Coronary

PMA numberP130030

Approval

Applicant
Boston Scientific Corp
Received
December 30, 2013
Decision date
March 10, 2026 (APPR)
Supplements
75, latest December 12, 2023
Product code
MAF – Stent, Coronary

Official FDA PMA record

Approval order statement

APPROVAL FOR THE REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THIS DEVICE IS 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.