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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAGENT Paclitaxel-Coated Balloon Catheter
Generic NameDrug-eluting percutaneous transluminal coronary angioplasty catheter
ApplicantBoston Scientific Corporation
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP230035
Supplement NumberS006
Date Received05/22/2025
Decision Date02/11/2026
Product Code OOB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a manufacturing site change to include Boston Scientific Ltd., located at Ballybrit Business Park, Galway, Ireland, for drug coating manufacturing, packaging and labeling for the Agent Monorail Paclitaxel Coated Balloon Catheter
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