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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 NumberS002
Date Received03/16/2020
Decision Date04/10/2020
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
In-process stent quality control changes, a component supplier manufacturing location change and part number changes.
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