- Device
- AGENT Paclitaxel-Coated Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P230035
- Supplement
- S006
- Product code
- OOB
- Generic name
- Drug-eluting percutaneous transluminal coronary angioplasty catheter
- Decision date
- 2026-02-11
- Decision code
- APPR
- Date received
- 2025-05-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing site change to include Boston Scientific Ltd., located at Ballybrit Business Park, Galway, Ireland, for drug coating manufacturing, packaging and labeling for the Agent Monorail Paclitaxel Coated Balloon Catheter