PMA P190019S039

Device: Ranger™ Paclitaxel-Coated PTA Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P190019
Supplement: S039
Product code: ONU
Decision date: 2025-10-24
Classification: Cardiovascular
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: combine the Ranger and Agent products into one sampling plan, change the batch definition to a week’s production and to test pre-sterilized devices for endotoxin

Current openFDA PMA Record#

Device: Ranger™ Paclitaxel-Coated PTA Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P190019
Supplement: S039
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2025-10-24
Decision code: OK30
Date received: 2025-09-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: combine the Ranger and Agent products into one sampling plan, change the batch definition to a week’s production and to test pre-sterilized devices for endotoxin