PMA P190019S008
- Device
- Ranger™ Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- Product code
- ONU
- Decision date
- 2021-04-20
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Implementation of additional analytical equipment for residual solvents batch release testing.
Current openFDA PMA Record#
- Device
- Ranger™ Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S008
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2021-04-20
- Decision code
- OK30
- Date received
- 2021-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of additional analytical equipment for residual solvents batch release testing.