- Device
- AGENT Paclitaxel-Coated Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P230035
- Supplement
- S003
- Product code
- OOB
- Generic name
- Drug-eluting percutaneous transluminal coronary angioplasty catheter
- Decision date
- 2025-03-09
- Decision code
- APPR
- Date received
- 2024-09-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternative site for analytical testing from Hemoteq to in house analytical labs.