PMA P230035S007

Device: AGENT™ Paclitaxel-Coated Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P230035
Supplement: S007
Product code: OOB
Decision date: 2025-10-24
Classification: Cardiovascular
Generic name: Drug-eluting percutaneous transluminal coronary 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: AGENT™ Paclitaxel-Coated Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P230035
Supplement: S007
Product code: OOB
Generic name: Drug-eluting percutaneous transluminal coronary 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