- Device
- Ranger™ Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S040
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2026-05-01
- Decision code
- APPR
- Date received
- 2025-11-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing process change to the port weld for the Ranger Paclitaxel-Coated PTA Monorail 200cm catheter