PMA P190019S004
- Device
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S004
- Product code
- ONU
- Decision date
- 2020-12-16
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval of the protocols for the post-approval studies (PAS) protocol.
Current openFDA PMA Record#
- Device
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S004
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2020-12-16
- Decision code
- APPR
- Date received
- 2020-11-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocols for the post-approval studies (PAS) protocol.