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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceAGENT Paclitaxel-Coated Balloon Catheter
Generic NameDrug-eluting percutaneous transluminal coronary angioplasty catheter
ApplicantBoston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP230035
Date Received10/05/2023
Decision Date02/29/2024
Product Code OOB 
Docket Number 24M-1081
Notice Date 03/08/2024
Advisory Committee Cardiovascular
Clinical TrialsNCT04647253
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
The AGENT Paclitaxel-Coated Balloon Catheter is intended to be used after appropriate vessel preperation in adult patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.0 mm to 4.0 mm in diameter and lesions up to 26 mm in length for the purpose of improving myocardial perfusion when treating in-stent restenosis (ISR).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002