PMA P190019S034
- Device
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S034
- Product code
- ONU
- Decision date
- 2024-12-11
- Classification
- Cardiovascular
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- approval for a 36-month shelf life for the Ranger Paclitaxel-Coated PTA Balloon Catheter
Current openFDA PMA Record#
- Device
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S034
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2024-12-11
- Decision code
- APPR
- Date received
- 2024-09-25
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for a 36-month shelf life for the Ranger Paclitaxel-Coated PTA Balloon Catheter