Boston Scientific Corporation,

The CDI officially issued the *Notice of Results of Overseas Inspection on Imported Medical Devices* covering your company’s AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter and Ranger Over-The-Wire Paclitaxel-Coated PTA Balloon Catheter Products on October 20, 2026, with a copy furnished to your registration agent, BSC International Medical Trading (Shanghai) Co., Ltd. Please check and confirm receipt thereof.

Should you have any inquiries, please contact us promptly.

Contact: Qin Shaoyan

Tel.+86 10 68441776

Center for Drug Inspection of NMPA
October 21, 2026