PMA P230035S009
- Device
- AGENT™ Paclitaxel-Coated Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P230035
- Supplement
- S009
- Product code
- OOB
- Decision date
- 2026-07-30
- Classification
- Cardiovascular
- Generic name
- Drug-eluting percutaneous transluminal coronary angioplasty catheter
- Approval order statement
- addition of Galway as an alternate manufacturing site for the balloon catheter sub-assembly
Current openFDA PMA Record#
- Device
- AGENT™ Paclitaxel-Coated Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P230035
- Supplement
- S009
- Product code
- OOB
- Generic name
- Drug-eluting percutaneous transluminal coronary angioplasty catheter
- Decision date
- 2026-07-30
- Decision code
- OK30
- Date received
- 2026-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of Galway as an alternate manufacturing site for the balloon catheter sub-assembly