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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 NumberS005
Date Received12/13/2024
Decision Date01/14/2025
Product Code OOB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the introduction of new Ethylene Oxide (EtO) sterilization chambers using existing cycles at the in-house sterilization facility in Galway, Ireland
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