- Device
- AGENT™ Paclitaxel-Coated Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P230035
- Supplement
- S005
- Product code
- OOB
- Generic name
- Drug-eluting percutaneous transluminal coronary angioplasty catheter
- Decision date
- 2025-01-14
- Decision code
- OK30
- Date received
- 2024-12-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the introduction of new Ethylene Oxide (EtO) sterilization chambers using existing cycles at the in-house sterilization facility in Galway, Ireland