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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
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantTerumo Medical Corporation
950 Elkton Blvd.
Hatagaya 151-0072
PMA NumberP140002
Supplement NumberS011
Date Received04/02/2018
Decision Date08/01/2018
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to the supplier of the device pouch.
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