PMA P190019S003
- Device
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- Product code
- ONU
- Decision date
- 2021-02-10
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for a 24 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
- S003
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2021-02-10
- Decision code
- APPR
- Date received
- 2020-11-17
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a 24 month shelf life for the Ranger Paclitaxel-Coated PTA Balloon Catheter.