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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 NumberS019
Date Received12/19/2018
Decision Date07/26/2019
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 modifications to the sterilization cycle parameters, loading configuration, and requirements for product release from the sterilization process.
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