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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
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantVeryan Medical, Ltd.
Unit 15, City Business Centre, Brighton Rd.
Horsham RH13 5BB
PMA NumberP180003
Supplement NumberS009
Date Received04/26/2024
Decision Date05/10/2024
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
changes to the instructions for use and other labelling in intended to enhance the safe in-use of the device.
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