PMA P190019S037
- Device
- Ranger™ Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S037
- Product code
- ONU
- Decision date
- 2025-02-12
- Classification
- Cardiovascular
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- an additional manufacturing line
Current openFDA PMA Record#
- Device
- Ranger™ Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S037
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2025-02-12
- Decision code
- OK30
- Date received
- 2025-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional manufacturing line