- Device
- RANGER™ Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S042
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2026-04-24
- Decision code
- OK30
- Date received
- 2026-03-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to the post-coating visual inspection procedures performed at Freudenberg Medical Hemoteq for the Ranger Paclitaxel-Coated PTA Balloon Catheter