PMA P190019S011
- Device
- RangerOver-The-Wire Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- Product code
- ONU
- Decision date
- 2023-03-24
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval to adjust the existing weld and trim equipment and process.
Current openFDA PMA Record#
- Device
- RangerOver-The-Wire Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S011
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2023-03-24
- Decision code
- APPR
- Date received
- 2022-01-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to adjust the existing weld and trim equipment and process.