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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® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantTerumo Medical Corporation
950 Elkton Blvd.
Hatagaya 151-0072
PMA NumberP140002
Supplement NumberS029
Date Received07/02/2025
Decision Date08/05/2025
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to replace the current ethylene oxide sterilizer with three other EO sterilizers at the same sterilization site
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