- Device
- Ranger™ Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S010
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2022-01-18
- Decision code
- OK30
- Date received
- 2021-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adoption of the Ranger Paclitaxel-Coated PTA Balloon Catheter into the reduced EO gas concentration version of the BSC2000-2 sterilization cycle.