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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.
 
DeviceBioMimics 3D Vascular Stent System
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantVeryan Medical Ltd.
Unit 15, City Business Centre, Brighton Rd
Horsham RH13
PMA NumberP180003
Supplement NumberS003
Date Received06/25/2020
Decision Date08/13/2020
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for updates to the labeling with final clinical data from the MIMICS-2 study.
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