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  1. Recently-Approved Devices

AGENT Paclitaxel-Coated Balloon Catheter – P230035

Picture of the AGENT Drug-Coated Balloon Catheter. Viewing from the left to the right of the picture, parts are identified as the drug-coated balloon and marker bands, midshaft, proximal marks, and manifold/strain relief

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: AGENT Paclitaxel-Coated Balloon Catheter
PMA Applicant: Boston Scientific Corporation
Address: One Scimed Place, Maple Grove, MN 55311
Approval Date: 02/29/2024
Approval Letter: Approval Order

What is it?

The AGENT Paclitaxel-Coated Balloon Catheter (Agent DCB) uses a narrow tube with a balloon on the end to reopen arteries that supply blood to the heart and are blocked or narrowed due to coronary artery disease (CAD). The balloon is coated on its outer surface with the drug paclitaxel, which may help prevent the arteries from narrowing again (restenosis).

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