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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 5BB
PMA NumberP180003
Supplement NumberS005
Date Received10/14/2021
Decision Date03/01/2022
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of an alternative sterilization site located at Synergy Health Sterilization UK Ltd, STERIS AST Unit 1, Alpha Court, Capitol Park, Thorne, DN8 5TZ, United Kingdom, addition of a new sterilization cycle, an alternative load configuration and ability to perform endotoxin testing on non-sterile samples in the current laboratory.
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