PMA P190019S015
- Device
- Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S015
- Product code
- ONU
- Decision date
- 2022-11-10
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Change to the cut to length manufacturing process.
Current openFDA PMA Record#
- Device
- Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S015
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2022-11-10
- Decision code
- OK30
- Date received
- 2022-10-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the cut to length manufacturing process.