PMA P190019S006

Device: Ranger Paclitaxel-Coated PTA Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P190019
Supplement: S006
Product code: ONU
Decision date: 2021-02-24
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: Adoption of the Ranger Paclitaxel-Coated PTA Balloon Catheter and Promus Everolimus-Eluting Coronary Stent System into the reduced EO gas concentration version of the BSC2000-2 sterilization cycle previously approved to sterilize other Boston Scientific Corporation (BSC) products.

Current openFDA PMA Record#

Device: Ranger Paclitaxel-Coated PTA Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P190019
Supplement: S006
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2021-02-24
Decision code: OK30
Date received: 2021-01-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Adoption of the Ranger Paclitaxel-Coated PTA Balloon Catheter and Promus Everolimus-Eluting Coronary Stent System into the reduced EO gas concentration version of the BSC2000-2 sterilization cycle previously approved to sterilize other Boston Scientific Corporation (BSC) products.