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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.
 
DeviceMISAGO(TM) RX Self-expanding Peripheral Stent
Generic NameSTENT, ILIAC
ApplicantTerumo Medical Corporation
950 Elkton Blvd.
Hatagaya 151-0072
PMA NumberP140002
Supplement NumberS032
Date Received12/29/2025
Decision Date07/16/2026
Product Codes NIO NIP 
Advisory Committee Cardiovascular
Clinical TrialsNCT02793492
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Misago RX Self-expanding Peripheral Stent is indicated to improve the luminal diameter in patient with de novo, restenotic and/or occlusive atherosclerotic lesion(s) in the common and/or external iliac artery. The reference vessel diameters range from 4.0 mm to 9.0 mm and the lesion length is up to 120 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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